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

Model Number 245124

Device Problem Contamination (1120)

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

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ mgit¿ 960 supplement kit contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "according to the customer's report, what appeared to be mold was found in the kit.".

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 supplement kit contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "according to the customer's report, what appeared to be mold was found in the kit.".

Manufacturer Narrative

H.6 investigation summary: git panta 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 by machine.The vials are lyophilized, and crimp caps are applied per standard operating procedures (sop).Mgit 960 growth 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.Six mgit panta vials are then manually packaged with six mgit growth supplement vials to make a mgit 960 supplement kit (material 245124).Panta batch number 1344144 was provided by the customer.Batch history review for panta batch 1344144 was satisfactory per internal procedure.Qc inspection and testing were satisfactory at time of release.Retentions were available for inspection for panta batch 1344144 (10 vials).No evidence of contamination was observed in 10/10 panta vials.For further investigation two panta vials were reconstituted with distilled water.One vial was placed into 20-25-degree celsius incubation and one vial was placed into 33-37-degree celsius incubation.At the end of a seven-day incubation period no microbial growth was observed in 2/2 incubated panta vials.For additional testing two panta vials were reconstituted with two supplement vials from batch 1344150.One vial was placed into 20-25-degree celsius incubation and one vial was placed into 33-37-degree celsius incubation.At the end of a seven-day incubation period no microbial growth was observed in 2/2 incubated panta vials.Four photos were received to assist with the investigation: the first photo shows a panta vial from batch 1344144.The vial is not crimp capped sealed and the vial has been reconstituted.The stopper has parafilm around it and there is possible fungal growth in the vial.The second photo shows a reconstituted panta vial with parafilm around the stopper.The third photo shows a reconstituted panta vial that has parafilm around the stopper.There appears to be possible fungal growth in the vial.The last photo shows a partially reconstituted panta vial from batch 1344144.There appears to be possible fungal growth in the vial.Returns were received to assist with the investigation.A shipping box was received with two other complaints.One reconstituted panta vial from batch 1344144 was received bubble wrapped in a plastic bag.The vial was uncrimped and the stopper was held in place with parafilm.There was growth in the vial.The vial was sent to bacterial identification.The growth was confirmed as mold; however, the mold did not grow and no viable organisms were identified.No 245124-kit batch number was provided to properly complete an investigation.Manufacturing records for panta batch 1344144 were reviewed and a probable kit batch number was found.Review of the probable kit batch number found the kit packaging process was satisfactory and there are no other complaints taken on the probable kit batch.No complaint trends have been identified with the probable kit batch.No quality notifications are associated with the probable kit batch.Bd will continue to trend complaints for contamination.No additional actions are indicated at this time.This complaint cannot be confirmed for a defect in a 245124 kit.Notes: risk management review indicates the potential risk of the defect reported was assessed as severity [s1], per [baltrmlmbactecmgitaph], rev [03], id [6.3].

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15135734
• MDR Text Key: 298699673
• Report Number: 1119779-2022-01046
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382902451242
• UDI-Public: 00382902451242
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 245124
• Device Catalogue Number: 245124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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