MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Catalog Number	442027
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd bactec¿ standard/10 aerobic/f culture vials (plastic) there was a molecular false positive for c.Tropicalis.There was no report of patient impact.The following information was provided by the initial reporter: customer is experiencing molecular false positives for c.Tropicalis on biofire bcid2.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following information has been updated describe event or problem: it was reported that during use with bd bactec¿ standard/10 aerobic/f culture vials (plastic) there was a molecular false positive for c.Tropicalis.There was no report of patient impact.The following information was provided by the initial reporter: customer is experiencing molecular false positives for c.Tropicalis on biofire bcid2.Enterobacterales and c.Tropicalis; serratia fonticola grew in culture; gram stain was gram negative rods.Correction: relevant tests/laboratory data: gram stain.Culture plate.
Event or Problem Description
It was reported that during use with bd bactec¿ standard/10 aerobic/f culture vials (plastic) there was a molecular false positive for c.Tropicalis.There was no report of patient impact.The following information was provided by the initial reporter: customer is experiencing molecular false positives for c.Tropicalis on biofire bcid2.Enterobacterales and c.Tropicalis; serratia fonticola grew in culture; gram stain was gram negative rods.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.B6: relevant tests/lab data: biofire result was a dual positive: staph spp., c.Tropicalis culture result: coag negative staph.Gram stain: gram positive cocci in clusters.H.6.Investigation summary: catalog: 442027, batch no.: 3117152.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 only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review results.
Event or Problem Description
Report 1 of 2: it was reported that during use with bd bactec¿ standard/10 aerobic/f culture vials (plastic) there was a molecular false positive for c.Tropicalis.There was no report of patient impact.The following information was provided by the initial reporter: customer is experiencing molecular false positives for c.Tropicalis on biofire bcid2.Enterobacterales and c.Tropicalis; serratia fonticola grew in culture; gram stain was gram negative rods.

• Brand Name: BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC)
• Common Device Name: 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17940870
• Report Number: 2647876-2023-00235
• Device Sequence Number: 6401446
• Product Code: MDB
• UDI-Device Identifier: 00382904420277
• UDI-Public: 00382904420277
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161810
• 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,Followup
• Report Date (Section B): 12/08/2023

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
• Operator of Device: Other
• Device Expiration Date: 04/29/2024
• Device Catalogue Number: 442027
• Device Lot Number: 3117152
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 12/07/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/14/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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