MAUDE Adverse Event Report: BD BBL; CULTURE MEDIA, SELECTIVE

Catalog Number 221734

Device Problems Microbial Contamination of Device (2303); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2014

Event Type  malfunction  

Event Description

The laboratory has received approximately 110 cdc anaerobe 5% sheep blood agar prepared plated media that were contaminated with listeria monocytogenes.Most of the plates have only one colony but some plates have several colonies.The colonies can be seen on the contaminated plates through the sealed packages straight out of the box with no incubation involved.
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manufacturer response for prepared plated media: cdc anaerobe 5% sheep blood agar, bbl cdc anaerobe 5% sheep blood agar (per site reporter).

• Brand Name: BBL
• Type of Device: CULTURE MEDIA, SELECTIVE
• Manufacturer (Section D): BD; 5859 farinon dr; ste 200; san antonio TX 78249
• MDR Report Key: 3816571
• MDR Text Key: 18069407
• Report Number: 3816571
• Device Sequence Number: 1
• Product Code: JSG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 221734
• Device Lot Number: 4077423
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2014
• Patient Sequence Number: 1