MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML; SYSTEM, BLOOD CULTURING

Catalog Number 245122

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 11/24/2023

Event Type  malfunction  

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 facility name: (b)(6) medical center.

Event Description

It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml has contaminated by foreign matter, customer noticed white sediment in the tube.There was no report of impact to patient or user.

Manufacturer Narrative

H.6 investigation summary: material 245122 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.As part of the release criteria for this product, the bhr is 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 there are three complaints for contamination.Retention samples from batch 3103482 (100 tubes) were available for inspection.There were 39/100 tubes found with contamination with a white spot in the bottom of the tube.For investigation, retention tubes were divided and incubated at 20-25 degrees celsius (19 tubes) and 30-35 degrees celsius (20 tubes).No growth was observed at 21 days incubation.No photos or returns were submitted for investigation of this complaint.This complaint can be confirmed for contamination by the retention samples.This product is not labeled as sterile.Media should be inspected prior to use and should not be used if medium shows evidence of contamination, drying, cracking or other signs of deterioration.No complaint trends for this complaint have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

Event Description

It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml has contaminated by foreign matter, customer noticed white sediment in the tube.There was no report of impact to patient or user.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
• 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: 18360113
• MDR Text Key: 331222910
• Report Number: 1119779-2023-01384
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: (01)30382902451229
• 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: 04/18/2024

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: 245122
• Device Lot Number: 3103482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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