FDA Adverse Event Malfunction Summary report: N

BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

MDR report key: 12138978 · Received July 8, 2021

Report

Report Number: 3008352382-2021-00175
Event Type: Malfunction
Date Received: July 8, 2021
Date of Event: May 25, 2021
Report Date: July 8, 2021
Manufacturer: BECTON DICKINSON CARIBE LTD.
Product Code: MDB
UDI-DI: 00382904420215
PMA / PMN Number: K123903
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1025377 MEDICAL DEVICE EXPIRATION DATE: 2021-11-30 DEVICE MANUFACTURE DATE: 2021-01-25. MEDICAL DEVICE LOT #: 1025349 MEDICAL DEVICE EXPIRATION DATE: 2021-11-30 DEVICE MANUFACTURE DATE: 2021-01-25. MEDICAL DEVICE LOT #: 1055889 MEDICAL DEVICE EXPIRATION DATE: 2021-12-31 DEVICE MANUFACTURE DATE: 2021-02-24. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE USING 3 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CONTAMINATION. "

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1032091	BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)	SYSTEM, BLOOD CULTURING	MDB	BECTON DICKINSON CARIBE LTD.	442021	1055889	00382904420215

Patients

Seq	Age	Sex	Outcome	Treatment
1