BBL SEPTI-CHEK 4343181

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-17 for BBL SEPTI-CHEK 4343181 manufactured by Becton Dickinson Microbiology Systems.

Event Text Entries

[13733] In 8/94, rptr's laboratory noted a cluster of candida guillermondii isolated from blood cultures. This oragnism is rarely isolated from blood cultures. Further, the organism was never isolated from more than one blood culture bottle and the pts from whom the organism was isolated did not have a clinical picture of fungal sepsis or risk for fungal disease. In other words, these isolates seemed to be contaminants. Rptr contacted mfr to alert them of this concern that they had a low level contamination of their aerobic blood culture system (bottles or slide chambers). At the time, rptr was assured that there had been no other complaints. However, in 11/94, rptr received an "important product notice" regarding sporadic rptr contamination of their subculture slides. Unfortunately, in spite of mfr's assurances to the contrary, it appears that they have not fixed the problem. Earlier this month, rptr encountered a candida guillermondii isolate from a single aerobic bottle that was morphologically and biochemically identical to those encountered last summer. The isolate was considered a contaminant by the pt's private internist as the pt had no risk factors for fungal infection and did not have a clinical course compatible with systemic fungal infection. Rptr has again contacted the mfr with his concerns about continuing contamination of their product. (*)
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1005493
• MDR Report Key: 20391
• Date Received: 1995-03-17
• Date of Report: 1995-03-03
• Date of Event: 1995-02-06
• Date Added to Maude: 1995-03-20
• 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: BBL SEPTI-CHEK
• Generic Name: MICROBIOLOGIC CULTURE MEDIA (DIAGNOSIS)
• Product Code: JSJ
• Date Received: 1995-03-17
• Catalog Number: 4343181
• Lot Number: 0518K41KB
• Device Expiration Date: 1995-06-05
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 20278
• Manufacturer: BECTON DICKINSON MICROBIOLOGY SYSTEMS
• Manufacturer Address: COCKEYSVILLE MD 21030 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1995-03-17