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

Catalog Number 442022

Device Problems Inaccurate Information (4051); Missing Information (4053)

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

Event Date 09/05/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) that there was no label or missing label information/ incorrect label information within 3 bottles.The following information was provided by the initial reporter: customer states 3 bottles were received with incorrect and missing labels.2 bottles had 2 different labels attached to them and 1 bottle the label was missing/peeled off.Total quantity of product showing defect: 10 bx received, 3 bottles affected customer states bottles are missing and have mismatched labels.

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.

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) that there was no label or missing label information/ incorrect label information within 3 bottles.The following information was provided by the initial reporter: customer states 3 bottles were received with incorrect and missing labels.2 bottles had 2 different labels attached to them and 1 bottle the label was missing/peeled off.Total quantity of product showing defect: 10 bx received, 3 bottles affected customer states bottles are missing and have mismatched labels.

Manufacturer Narrative

H.6 investigation summary customer reports damage bactec vials labels.Photo were provided.Double/multiple and missing vial label were observed.Bd was unable to reproduce customer¿s experience with the bactec product.Satisfactory results were obtained from retention samples when visually inspected.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.Batch history record review did not identify any evidence for which the customer submitted the complaint.A technical assessment was performed by the engineering department to determine if the labeler had mechanical issues and/or breakdowns during the labeling process of aforementioned batch.Investigation revealed that preventive maintenance to the machine was completed on time as scheduled.Upon evaluation of breakdowns / incidents reports there were no double/missing vial label problems reported on that date.After evaluating the production reports several jams were reported.There are controls in place to remove this type of defects.These types of issues related with bottles jams are resolved during the labeling process.Complaint is confirmed based on photo sent by the customer.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.Do not use any vial showing evidence of contamination.Prior to use, the user should examine the vials for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.

• Brand Name: BD BACTEC¿ PLUS ANAEROBIC/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: 17830885
• MDR Text Key: 324434758
• Report Number: 2647876-2023-00194
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420222
• UDI-Public: 00382904420222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141810
• 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: 11/01/2023

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: 12/20/2023
• Device Catalogue Number: 442022
• Device Lot Number: 3074406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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