BD BBL PORT-A-CUL ENVELOPE 221607 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-21 for BD BBL PORT-A-CUL ENVELOPE 221607 * manufactured by Becton, Dickinson And Company.

Event Text Entries

[20793211] The microbiology lab had followed up on a confusing artifact seen in the becton dickinson (bd) bbl port-a-cul anaerobic transport media. It looked like a gram variable rod but was non-viable. At the time decision was made to in-service the lab staff to recognize the artifact so it would not be reported as an organism. Since the organism was non-viable, and there was no danger of the lab working it up on the culture, the decision made to educate staff not to report these artifacts on the gram stain we could continue to use them until a replacement product was found. In-servicing and related e-mail took place but the education process failed as a result of the surgery and the report of rare gram neg rods. A surgery took place and a stat gram neg specimen sent to the lab. The results were inconclusive. Findings were of rare gram negative rods. A tissue sample was then sent rather than swab. The culture medium was cultured and gram negative rods were found. The lab contacted bd technical service and informed the package insert for the product states: transport media sometimes contain dead organisms visible upon gram staining. Scripps has requested an internal recall of this product and remove it from all sites. ======================manufacturer response for anaerobic transport media, bd bbl port-a-cul envelope (per site reporter). ======================instructed to review package insert.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2398835
• MDR Report Key: 2398835
• Date Received: 2011-12-21
• Date of Report: 2011-12-21
• Date of Event: 2011-12-17
• Report Date: 2011-12-21
• Date Reported to FDA: 2011-12-21
• Date Added to Maude: 2012-01-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BD BBL PORT-A-CUL ENVELOPE
• Generic Name: ANAEROBIC TRANSPORT MEDIA
• Product Code: JTX
• Date Received: 2011-12-21
• Model Number: 221607
• Catalog Number: *
• Lot Number: 1168822 LANE 5
• ID Number: *
• Device Availability: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON, DICKINSON AND COMPANY
• Manufacturer Address: 150 SOUTH FIRST AVE BROKEN BOW NE 68822 US 68822

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-12-21