MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 PZA KIT; SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Model Number 245128

Device Problem Non Reproducible Results (4029)

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

Event Date 03/03/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 pza kit atypical growth was observed by the laboratory personnel.The customer stated that results were reported out, but there was no report of patient impact the following information was provided by the initial reporter: it was reported by the customer that they had a discrepant pza result.

Manufacturer Narrative

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 while using bd bactec¿ mgit¿ 960 pza kit atypical growth was observed by the laboratory personnel.The customer stated that results were reported out, but there was no report of patient impact the following information was provided by the initial reporter: "it was reported by the customer that they had a discrepant pza result.".

Manufacturer Narrative

H.6.Investigation summary mgit 960 pza kit batch 1217983 is composed of mgit pza batch 1168876 and mgit 960 pza supplement batch 0352570.The batch history record review for mgit 960 pza kit batch 1217983 was satisfactory.No quality notifications were generated during manufacturing and one other complaint has been taken on this batch for performance.Bactec mgit 960 pza is manufactured by rehydrating components in usp purified water and mixed into a homogenous solution.The solution is then sterile filtered, dispensed into vials and stoppered.The vials are lyophilized, and crimp caps are applied per standard operating procedures (sop).Bactec mgit 960 pza supplement is manufactured by rehydrating the media components with usp purified water and mixed until a homogeneous solution is obtained.The solution is then sterile filtered and dispensed into vials; stoppers are manually placed in the vial opening; septum caps are manually placed on top of the stopper and then mechanically crimped per sop.Two bactec mgit 960 pza vials are then manually packaged with six bactec mgit 960 pza supplement vials to complete a bactec mgit 960 pza kit (material 245128).The batch history record reviews for mgit pza batch 1168876 and mgit pza supplement batch 0352570 were satisfactory, and no quality notifications were generated during manufacturing and inspection.The formulation processes were each within specification, and qc inspection and testing were satisfactory at time of release.Retention samples from pza supplement batch 0352570 (4 vials) and pza batch 1168876 (10 vials) were available for inspection.No defects were observed in any of the retention vials from visual inspection.Retentions were performance tested for growth.All retention sample testing was satisfactory per procedures.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for performance issues.

• Brand Name: BD BACTEC¿ MGIT¿ 960 PZA KIT
• Type of Device: SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13961324
• MDR Text Key: 288268080
• Report Number: 1119779-2022-00485
• Device Sequence Number: 1
• Product Code: MJA
• UDI-Device Identifier: 00382902451280
• UDI-Public: 00382902451280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021582
• 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: 06/26/2022

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: 06/16/2022
• Device Model Number: 245128
• Device Catalogue Number: 245128
• Device Lot Number: 1217983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 06/26/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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