MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT; SYSTEM, BLOOD CULTURING

Catalog Number 245124

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported when using the bd bactec¿ mgit¿ 960 supplement kit 1 vial came in without any label.There was no report of impact to patient or user.

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.E.4.Initial reporter city: (b)(6).

Event Description

It was reported when using the bd bactec¿ mgit¿ 960 supplement kit 1 vial came in without any label.There was no report of impact to patient or user.

Manufacturer Narrative

: the components of kit batch 3201348 were reviewed and all batch history records were satisfactory at time of release per internal procedures.Performance of each kit component was satisfactory per procedures.Retention samples were inspected for supplement batch 3115963 (8 vials) and panta batch 3158338 (10 vials).There were no missing labels observed in any of these retention samples inspected.For this product, retention samples are maintained as individual components and no complete cartons were available for inspection.The complaint history was reviewed, and no other complaints have been taken on batch 3201348.Nine photos were received to assist with the investigation.Seven photos seem to be screenshots of sections of a website.One photo is of kit label batch 3201348.One photo shows a reconstituted vial with no label.No returns were available for investigation of this complaint.This complaint can be confirmed for a missing label based on the evidence provided by the photos received.No complaint trends have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for packaging defects such missing labels.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18416151
• MDR Text Key: 331731133
• Report Number: 1119779-2023-01442
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382902451242
• UDI-Public: (01)00382902451242
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K974883
• 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: 04/03/2024

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 Catalogue Number: 245124
• Device Lot Number: 3201348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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