FDA 483 - Huntington Memorial Hospital - December 11, 2015

The FDA Form 483 details observations from an inspection of a user facility regarding medical device reporting (MDR) deficiencies.

The facility failed to submit FDA Form 3500A or equivalent to the FDA and device manufacturer within ten working days for a patient death. Specifically, an MDR for a patient who expired due to multiorgan failure following a procedure was submitted as an "Adverse Event" without indicating death, and was submitted on 11/10/15 despite awareness on 10/29/15.

Another patient death on 10/29/14, due to sepsis after an ERCP procedure, was not reported to the FDA or manufacturer, despite the facility becoming aware on 11/10/15 of bacterial DNA fingerprinting results linking the infection to contaminated duodenoscopes.

The facility also failed to submit Form 3500A or equivalent within ten working days for serious injuries. Two MDRs for patients with infections following procedures were submitted on 11/10/15, but should have been submitted earlier.

Furthermore, written MDR procedures have not been fully implemented. The Medical Device Reporting Program procedure (Policy #117, dated 5/2013) requires MDR event files (Incident Files). On 11/10/15, the facility became aware of DNA fingerprinting results linking 11 multidrug-resistant