BACT ALERT BLOOD CULTURE BOTTLE 59269

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-05 for BACT ALERT BLOOD CULTURE BOTTLE 59269 manufactured by Organon Teknika Corp..

Event Text Entries

[21433] Lab blood culture medium contained gram-positive bacteria that were not viable, but led rptr to conclude that they were in the culture of the pt's specimen. Only one lot of media was affected. 10 bottles which were known to be negative for growth of organisms were gram stained and found to contain gram-positive cocci. Ten bottles from a different lot number were found to be negative by gram stain. For two pts, positive reports were given to the physicians. Until the problem was resolved those reports remained in the pt's chart. In one case, the report was in the computer for 2 weeks; in the other, for 4 days.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1008069
• MDR Report Key: 29260
• Date Received: 1996-01-05
• Date of Report: 1996-01-03
• Date of Event: 1996-01-03
• Date Added to Maude: 1996-01-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BACT ALERT BLOOD CULTURE BOTTLE
• Generic Name: CULTURE MEDIUM
• Product Code: JSC
• Date Received: 1996-01-05
• Catalog Number: 59269
• Lot Number: 203314
• Device Expiration Date: 1996-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 30282
• Manufacturer: ORGANON TEKNIKA CORP.
• Manufacturer Address: 100 AKZO AVE DURHAM NC 27704 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1996-01-05