TRYPTIC SOY BROTH * 221715

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-07 for TRYPTIC SOY BROTH * 221715 manufactured by Becton Dickinson Co..

Event Text Entries

[15740400] Pt admitted for revision of a right knee replacement related to mechanical complications. A gramstain done on surgically obtained tissue was falsely positive due to the broth used. The tsb broth used to grind tissue had non-viable gram positive cocci in pairs and chains. No signs of inflammation at surgical site or pathology specimen. Cultures all negative. Pt placed on long term antibiotic therapy with vancomycin and cefepine. Broth sterility test 25/35 c no growth, gram stain positive for pairs and chains. Mfr of broth contacted about elevated level of nonviable bacteria.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033949
• MDR Report Key: 562474
• Date Received: 2004-12-07
• Date of Report: 2004-12-07
• Date of Event: 2004-09-28
• Date Added to Maude: 2005-01-03
• 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 Sequence Number: 1

• Brand Name: TRYPTIC SOY BROTH
• Generic Name: MEDIA FOR BACTERIAL CULTURE
• Product Code: JSC
• Date Received: 2004-12-07
• Returned To Mfg: 2004-10-27
• Model Number: *
• Catalog Number: 221715
• Lot Number: 4156611
• ID Number: *
• Device Expiration Date: 2005-12-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 552192
• Manufacturer: BECTON DICKINSON CO.
• Manufacturer Address: * SPARKS MD 21152 US

Device Sequence Number: 2

• Brand Name: TRYPTIC SOY BROTH
• Generic Name: MEDIA FOR BACTERIAL CULTURE
• Product Code: JSC
• Date Received: 2004-12-07
• Returned To Mfg: 2004-10-27
• Model Number: *
• Catalog Number: 221716
• Lot Number: 4156611
• ID Number: *
• Device Expiration Date: 2005-12-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 552196
• Manufacturer: BECTON DICKINSON CO.
• Manufacturer Address: * SPARKS MD 21152 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-12-07