BECTON DICKENSON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-11 for BECTON DICKENSON * manufactured by *.

Event Text Entries

[272752] They are the dept of public health and environment. Two of their hosps have been using the becton dickinson test kits for detecting cryptosporidium and giardia. The test kits are giving false positive results for both pathogens.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1024390
• MDR Report Key: 381984
• Date Received: 2002-03-11
• Date of Report: 2002-03-11
• Date Added to Maude: 2002-03-18
• 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
• 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: BECTON DICKENSON
• Generic Name: CRYPTO/GIARDIA TEST KITS
• Product Code: MHJ
• Date Received: 2002-03-11
• Model Number: *
• Catalog Number: *
• Lot Number: 215934
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 371033
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: BECTON DICKENSON
• Generic Name: CRYPTO/GIARDIA TEST KITS
• Product Code: MHJ
• Date Received: 2002-03-11
• Model Number: *
• Catalog Number: *
• Lot Number: 181165B
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 371035
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 3

• Brand Name: BECTON DICKENSON
• Generic Name: CRYPTO/GIARDIA TEST KITS
• Product Code: MHJ
• Date Received: 2002-03-11
• Model Number: *
• Catalog Number: *
• Lot Number: 181168
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 3
• Device Event Key: 371037
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-03-11