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

Catalog Number 245122

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml customer noticed a white haze, and it grew a gram staining revealed gram-negative bacilli.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.

Manufacturer Narrative

The following fields were updated due to corrected information: e.1.Initial reporter first name: (b)(6) h.6 imdrf annex a grid: a0908 - incorrect, inadequate or imprecise result or readings d9: device available for evaluation: yes, d.9:device eval by manufacturer? yes, d9: returned to manufacturer on: 15-apr-2024.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 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 14 days incubation.When the tubes with the white spots were shaken, the spot dispersed into particles in solution.Eight photos were submitted for investigation of this complaint.Two photos showed the carton, batch 3103482.One photo showed an open carton with the tube caps visible.Five photos showed a white ring around the tube below the bottom of the tube label.There were 200 tubes returned to assist in the investigation of this complaint.Two 100 pack cartons were received in a box with bubble wrap and air bubbles.One hundred tubes were incubated in a 20 to 25 degree celsius incubator.One hundred returned tubes were incubated in a 33 to 37 degree celsius incubator.At 14 days, there was no growth in any of the tubes.There were no defects noticed in the returned tubes.This complaint can be confirmed for particles from 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.

Event Description

It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml customer noticed a white haze, and it grew a gram staining revealed gram-negative bacilli.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: 18330541
• MDR Text Key: 330935410
• Report Number: 1119779-2023-01370
• 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: 05/07/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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