MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Catalog Number 442023

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), customer had biofire false positive for c.Tropicalis.This is a report of one occurrence.The following information was provided by the initial reporter: customer reported biofire false positives for c.Tropicalis.No yeast grew and gram stains did not show yeast.Biofire false positive for c.Tropicalis.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details emailing for details.

Manufacturer Narrative

G5: pma/510(k)#: one additional code applies; k222591.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), customer had biofire false positive for c.Tropicalis.This is a report of one occurrence.Some results were reported to clinicians.The following information was provided by the initial reporter: customer reported biofire false positives for c.Tropicalis.No yeast grew and gram stains did not show yeast.Biofire false positive for c.Tropicalis.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details emailing for details.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.B.5.Describe event or problem: it was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), customer had biofire false positive for c.Tropicalis.This is a report of one occurrence.Some results were reported to clinicians.The following information was provided by the initial reporter: customer reported biofire false positives for c.Tropicalis.No yeast grew and gram stains did not show yeast.Biofire false positive for c.Tropicalis.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details emailing for details.H.6.Investigation summary: customer reported a molecular false positive result.Neither photos nor returned good samples were received.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted, and batch has been previously investigated for the reported defect.Complaint is unconfirmed based on retention samples and batch history record review results.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• 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: jennifer suh ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18013038
• MDR Text Key: 326631181
• Report Number: 2647876-2023-00366
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: (01)00382904420239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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: 01/19/2024
• Device Catalogue Number: 442023
• Device Lot Number: 3102728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/26/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1