MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS; BLOOD CULTURING SYSTEM

Model Number	442191
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 bd bactec¿ standard anaerobic/f culture vials from lot 1027294, and 2 bottles from lot 1061248 produced false positive results with the bactec media.Gram stains were tested, which produced negative results.There was no indication that results were reported to clinicians, and there was no report of adverse patient impact.The following information was provided by the initial reporter: "customer had 5 false positives flag recently.Nothing seen in gram stains.No temperature issues noted.Only one patient had a high wbc.Customer does not believe the bottles were overfilled.".
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1027294, medical device expiration date: 2021-11-30, device manufacture date: 2021-01-27.Medical device lot #: 1061248, medical device expiration date: 2021-12-31, device manufacture date: 2021-03-02.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: 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.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.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.No correctives actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.
Event or Problem Description
It was reported that 3 bd bactec¿ standard anaerobic/f culture vials from lot 1027294, and 2 bottles from lot 1061248 produced false positive results with the bactec media.Gram stains were tested, which produced negative results.There was no indication that results were reported to clinicians, and there was no report of adverse patient impact.The following information was provided by the initial reporter: "customer had 5 false positives flag recently.Nothing seen in gram stains.No temperature issues noted.Only one patient had a high wbc.Customer does not believe the bottles were overfilled.".

• Brand Name: BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS
• Common Device Name: BLOOD CULTURING SYSTEM
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12620720
• Report Number: 2647876-2021-00193
• Device Sequence Number: 17229409
• Product Code: MDB
• UDI-Device Identifier: 00382904421915
• UDI-Public: 00382904421915
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K915796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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
• Operator of Device: Other
• Device Model Number: 442191
• Device Catalogue Number: 442191
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown