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 08/13/2023

Event Type  malfunction  

Event Description

Report 1 of 5 it was reported that bd bactec¿ plus aerobic/f culture vials (plastic) candida tropicalis false positive occurred.The following information was provided by the initial reporter: bactec 442023 molecular false positive what results were reported to clinicians and was patient treatment affected in response? in two cases, candida tropicalis was reported, the other three cases, candida tropicalis result was not reported.What organisms were seen on gram stain? gram positive cocci, yeast (with no growth of c.Tropicalis.C parapsilosis grew in this case); gnr.What organisms grew on culture plate? strep pneumoniae, candida parapsilosis, staph epidermidis, serratia marcescens.

Manufacturer Narrative

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

Report 1 of 5.It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) candida tropicalis false positive occurred.The following information was provided by the initial reporter: bactec 442023 molecular false positive.What results were reported to clinicians and was patient treatment affected in response? in two cases, candida tropicalis was reported, the other three cases, candida tropicalis result was not reported.What organisms were seen on gram stain? gram positive cocci, yeast (with no growth of c.Tropicalis.C parapsilosis grew in this case); gnr.What organisms grew on culture plate? strep pneumoniae, candida parapsilosis, staph epidermidis, serratia marcescens.

Manufacturer Narrative

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 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.No corrective 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 investigational process.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17764958
• MDR Text Key: 323618268
• Report Number: 3008352382-2023-00141
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 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: 12/26/2023

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: 11/09/2023
• Device Catalogue Number: 442023
• Device Lot Number: 3033390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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