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

Catalog Number 442023

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported when using bd bactec¿ plus aerobic/f culture vials the customer reported false negative results.There was no report of impact to patient or user.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary catalog 442023; batch no.3145929.Customer reported a false negative result.Two photos of bactec bottles were received.Bd was unable to reproduce customer¿s experience with bactec product.Satisfactory results were obtained from retention samples when tested for microbial instrument detection as per quality procedures.Batch history record review did not identify any evidence for which the customer submitted the complaint (i.E.False negative).Microbial instrument detection indicated that the product is performing as expected.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 record review results.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.The specimen must be collected using sterile techniques to reduce the chance of contamination.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.

Event Description

It was reported when using bd bactec¿ plus aerobic/f culture vials the customer reported false negative results.There was no report of impact to patient or user.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18385313
• MDR Text Key: 331493815
• Report Number: 2647876-2023-00667
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: (01)00382904420239
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: 02/26/2024
• Device Catalogue Number: 442023
• Device Lot Number: 3145929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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