MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC; PEDS PLUS;/ F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Model Number 442020

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while testing with bd bactec¿; peds plus¿;/ f culture vials a false positive result was obtained.Confirmation testing performed, the bottles were sown in differential culture media and no microorganism growth was obtained.Results were not reported and there was no reported patient impact.

Manufacturer Narrative

H.6.Investigation: customer reported a false positive defect.Bd was unable to reproduce customer experience with the bactec product.A false positive response was not observed when retention samples were tested.Batch history records were reviewed, and all testing were within specification for product release.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.Complaint is unconfirmed based on retention samples and batch history record review.

Event Description

It was reported while testing with bd bactec¿; peds plus¿;/ f culture vials a false positive result was obtained.Confirmation testing performed, the bottles were sown in differential culture media and no microorganism growth was obtained.Results were not reported and there was no reported patient impact.

• Brand Name: BD BACTEC; PEDS PLUS;/ F CULTURE VIALS
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11381799
• MDR Text Key: 280447338
• Report Number: 3008352382-2021-00055
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: 00382904420208
• Combination Product (y/n): N
• PMA/PMN Number: K151866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 442020
• Device Catalogue Number: 442020
• Device Lot Number: 0225298
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1