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 (1120)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter initial reporter facility name: (b)(6).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 that bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml had fungal contamination.No patient impact reported.

Event Description

It was reported that bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml had fungal contamination.No patient impact reported.

Manufacturer Narrative

H.6.Investigation summary: the batch history record review for batch 3129937 was satisfactory per internal procedures.Formulation, filling, torqueing, packaging processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.The complaint history was reviewed, and one other complaint has been taken on this batch for fill volume and contamination.Retention samples from batch 3129937 (100 tubes) were available for inspection.All 100 retentions were visually inspected and there were no signs of contamination or obvious low fill volume in any of the retention samples.For investigation, retention tubes were incubated at 20-25 degrees c (5 tubes) and 30-35 degrees c (5 tubes) and no turbidity was observed at 7 days incubation.Two (2) photos were received for review for this complaint.The first photo shows a single tube held above a tube rack.The tube has a visibly low fill with contamination swirling throughout the medium.The second photo shows a hand holding two tubes.The two tubes both have low fill volumes.The tube on the right shows batch 3129937 and expiration 2024-11-03.No returns were received for investigation.The complaint can be confirmed.No complaint trends for this defect have been identified for this product; no actions are identified at this time.Bd will continue to trend complaints for defects.H3 other text : see h10.

• 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: 18228761
• MDR Text Key: 329260414
• Report Number: 1119779-2023-01270
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: (01)30382902451229
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/28/2024

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: 3129937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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