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 10/09/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), there were an unspecified number of molecular false positive results.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting molecular false positives for product 442023.".

Manufacturer Narrative

There were multiple 510k numbers reported to be involved.The information is as follows: g.5.Pma / 510(k)#: k222591.

Manufacturer Narrative

H.6.Investigation summary: catalog: 442023.Batch no.: unknown.Customer reported a molecular false positive result.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), there were an unspecified number of molecular false positive results.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting molecular false positives for product 442023.".

• 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: 18015594
• MDR Text Key: 326965278
• Report Number: 2647876-2023-00374
• 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: 11/23/2023

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 Catalogue Number: 442023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/23/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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