TRYPTICASE SOY BROTH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-20 for TRYPTICASE SOY BROTH * manufactured by Becton Dickinson.

Event Text Entries

[19495686] Facility has detected contaminated, but sterile medium from becton dickinson. It is trypticase soy broth lot #5283649 that outdates 4/6/07. This problem was detected when facility had pt specimens whose gram stains showed gram positive cocci, but for whom there was no growth on culture. The swab specimens had been placed in "sterile" tsb to elute the specimen so that the material could be used to prepare a smear and inoculate culture plates.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038041
• MDR Report Key: 676195
• Date Received: 2006-02-16
• Date of Report: 2006-01-20
• Date of Event: 2006-01-19
• Date Added to Maude: 2006-02-16
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: TRYPTICASE SOY BROTH
• Generic Name: *
• Product Code: JSH
• Date Received: 2006-01-20
• Model Number: *
• Catalog Number: *
• Lot Number: 5283649
• ID Number: *
• Device Expiration Date: 2007-04-06
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 665472
• Manufacturer: BECTON DICKINSON
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-02-16