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 11/20/2023

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.

Event Description

It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml customer found contaminated medium.

Manufacturer Narrative

H6: investigation summary: batch history record review for batch 3071069 was per internal procedures.Formulation, filling, torquing, and autoclaving processes were within specifications.The release testing that is performed on this product includes media appearance.In process checks are performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures.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 no other complaints for low fill.Retention samples from batch 3081069 (100 tubes) were available for inspection.Retention samples were inspected, and 0/100 tubes had loose caps/leaking, had less than expected media volume or had microbial growth.There was one photo received to assist with the investigation.The photo showed two tubes.Both tubes appeared to have growth with one tube showing low fill.Batch information could not be seen on the labels from the photo for verification.No returns were received for investigation of this complaint.This complaint cannot be confirmed for leaking from the photo provided.Contamination nor low fill can be verified because the tube labels are not oriented to view the batch number in the photos.Bd will continue to trend complaints for leaking tubes, fill volume and contamination.

Event Description

It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml customer found contaminated medium.

• 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: 18319257
• MDR Text Key: 330963601
• Report Number: 1119779-2023-01362
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: (01)30382902451229
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 04/23/2024

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: 3081069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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