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

Catalog Number 442192

Device Problem Inaccurate Information (4051)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

G5.Pma/510k #:k921133 k083572.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 bd bactec¿ plus aerobic/f culture vials had label discrepancies.The following information was provided by the initial reporter: the agemed agency informs the general population that, through special inspections carried out, it has become aware of the commercialization of the bd bactec peds plus/f culture vials (plastic) 40ml and bd bactec plus aerobic/f culture vials 30ml reagents with label adulterated in the place where it declares the lot and expiration date, therefore, agemed does not guarantee compliance with the criteria of quality, safety and/or effectiveness of the reagents.

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials had label discrepancies.The following information was provided by the initial reporter: the agemed agency informs the general population that, through special inspections carried out, it has become aware of the commercialization of the bd bactec peds plus/f culture vials (plastic) 40ml and bd bactec plus aerobic/f culture vials 30ml reagents with label adulterated in the place where it declares the lot and expiration date, therefore, agemed does not guarantee compliance with the criteria of quality, safety and/or effectiveness of the reagents.

Manufacturer Narrative

H3.Investigation summary: the agemed agency informs the general population that, through special inspections carried out, it has become aware of the commercialization of the bd bactec peds plus/f culture vials (plastic) 40ml and bd bactec plus aerobic/f culture vials 30ml reagents with label adulterated in the place where it declares the lot and expiration date, therefore, agemed does not guarantee compliance with the criteria of quality, safety and/or effectiveness of the reagents.Photos were provided.Bd was unable to reproduce customer experience with bactec¿ product.Upon further evaluation it was noticed that complaint received was from a product already expired.Investigation cannot be conducted to the retention samples since the product is already expired.Batch history records review did not identify any evidence from 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.The product insert warnings and precautions sections state that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depressed 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.Bd has controls in place to avoid counterfeit bactec vial labels.There is an incoming inspection procedure to verify the vial labels.Labels are inspected by the labeling vision system of each line.A process control technician inspects one (1) case every hour for completeness, legible and correct batch, and expiration date.All bactec vial labels for plastic product are printed with a 2d barcode in the black box where the batch and expiration date are located.An over label is seen in the lot and date section of the vial label in complaint photo.The corners of the labels are smaller and straight as for the current artworks, the labels corners are rounder in shape.Complaint is confirmed based on photos.The product was counterfeited outside of bd cayey.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.H3 other text : see h10.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17786836
• MDR Text Key: 323896990
• Report Number: 3008352382-2023-00155
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: BL
• PMA/PMN Number: K083572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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: 06/30/2022
• Device Catalogue Number: 442192
• Device Lot Number: 1243414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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