FDA WARNING_LETTER - Wake Forest University Baptist Medical Center - November 19, 2009

On April 7, 2010, the FDA issued a Warning Letter to Wake Forest University Baptist Medical Center following an inspection from October 26 to November 19, 2009. The inspection revealed the hospital's use of (b)(4) and (b)(4) devices, which are subject to Medical Device Reporting (MDR) regulations. The facility was cited for misbranding devices under section 502(t)(2) of the Act due to failure to furnish required information under section 519 and 21 C.F.R. Part 803.

Violations included: 1. **Failure to submit death reports within 10 work days [21 CFR 803.30(a)(1)]**: A patient died from internal hemorrhage after a (b)(4) device use. The hospital's revised Risk Management procedure (10/02/09) was deemed adequate. 2. **Failure to submit serious injury reports within 10 work days [21 CFR 803.30(a)(2)]**: Three serious injuries were not reported or not reported timely. The revised Risk Management procedure (10/02/09) addressing timely reporting was deemed adequate. 3. **Failure to maintain MDR event files with decision-making processes [21 CFR 803.18(b)(