FDA 483 - Allegheny General Hospital - December 17, 2015

The FDA inspection of a user facility revealed multiple violations related to medical device reporting (MDR) requirements. The facility failed to submit FDA Form 3500A or its electronic equivalent to the FDA and the device manufacturer within ten working days after becoming aware of information suggesting a Duodenoscope and/or central line contributed to a patient's death. This patient had positive CRE cultures and died on a redacted date, with the infection report indicating a hospital and central-line associated infection.

Additionally, the facility did not submit FDA Form 3500A to the known device manufacturer within ten working days for a serious injury case where a Duodenoscope contributed to a patient's injury, with cultures positive for ESCHERICHIA COLI FMW Presumptive Carbapenemase producer Isolate.

The facility's written MDR procedures (Policy Manual No. 9018) have not been fully implemented, lacking documentation of adherence to policy guidelines. MDR event files were incomplete, missing adverse event information and documentation of reportability decisions. A submitted FDA Form 3500 for a serious injury was incorrect, as mandatory FDA Form 3500A was required. This form also omitted reasonably known information such as patient weight, follow-up, treatment, brand name, product code, model, and lot number. Finally, the written MDR procedure does not specify timely transmission of complete reports, specifically that death reports must go to both FDA