MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP); SYSTEM, BLOOD CULTURING

Catalog Number 245113

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

It was reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (100/sp) had biological contamination which led to false results.This occurred 4 times.There was no report of patient impact.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with additional information: d10.Device available for eval- yes.D10.Returned to manufacturer on: 17-nov-2023.H3.Device returned to manufacturer- yes.H3.Device eval by manufacturer- yes.H.6.Investigation summary: material 245113 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The media is dispensed into bottles; caps are applied manually then torqued by machine per a standard operating procedure (sop).The bottles are then labeled and terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, bottles are packaged into final shipping configurations.The batch history record review for batch 3025464 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr was reviewed to confirm the following: --the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.--all autoclave parameters conformed to the validated cycle parameters for this product.--the minimum f0 for this product was met.The complaint history was reviewed, and one other complaint has been taken on batch 3025464.Retention samples from batch 3025464 (100 tubes) were available for inspection.There were zero contamination defects observed in 100/100 retention tubes from visual inspection.Ten (10) uninoculated retention tube was placed into incubation to test for contamination.Five (5) tubes were placed into the 20 to 25 degrees celsius incubator and five (5) tubes were placed into the 33-to-37-degree celsius incubator.At seven days incubation, there were no traces of microbial growth in the incubated retention tubes.There were three (3) photos received to assist in the investigation of batch 3025464.Six (6) unused returns were received in a zip lock bag in a box with air bubbles to assist with the investigation.Three (3) returned unused tubes were placed into the 20 to 25 degrees celsius incubator and three returned unused tubes were placed into the 33-to-37-degree celsius incubator.At twenty-two (22) days of incubation, there was no growth in the 6 incubated tubes.There were three photos received to assist in the investigation of batch 3025464.One photo was of an open box of tubes with on the top of the caps visible with no batch identification.There was one photo of a tube on its side with the label visible (batch 3025464).The third photo was of a microscope slide with writing.There were forty-eight (48) tubes and one box with a glass slide returned for investigation of batch 3025464.The tubes were in a 100-pack carton, padded with bubble wrap in a zip lock bag inside of a box.The box was with returns for three other complaints.Twenty-four (24) returned tubes were incubated in a 20 to 25 degrees celsius incubator and 24 returned tubes were incubated in a 33 to 37 degrees celsius incubator for 25 days.At 25 days, the was no growth in the 48 tubes.The photos do not confirm contamination.The incubated retention tubes nor returns exhibited no growth after incubation.This complaint cannot be confirmed.This product is not labeled as sterile.Prior to use, each mgit tube should be examined for evidence of contamination or damage.Discard any tubes if they appear unsuitable or exhibit fluorescence prior to use.For tubes that have been put into test and have suspect contamination, it is possible to reprocess contaminated mgit tubes.See the package insert for details for this procedure.

Event Description

It was reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (100/sp) had biological contamination which led to false results.This occurred 4 times.There was no report of patient impact.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP)
• 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: 18147880
• MDR Text Key: 328266434
• Report Number: 1119779-2023-01237
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451137
• UDI-Public: (01)30382902451137
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954932
• 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: 03/29/2024

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 Expiration Date: 01/20/2024
• Device Catalogue Number: 245113
• Device Lot Number: 3025464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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