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 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 prior to use, one bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml was contaminated with fungus.The following information was provided by the initial reporter: 10 mgit tubes with one having fungal growth found.

Event Description

It was reported that prior to use, one bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml was contaminated with fungus.The following information was provided by the initial reporter: 10 mgit tubes with one having fungal growth found.

Manufacturer Narrative

H.6.Investigation summary: the batch history record for batch 3103446 was satisfactory per internal procedures.The complaint history was reviewed, and no other complaints have been taken on batch 3103446 for contamination.One other complaint for fill volume was taken but also not confirmed.Retention samples from batch 3103446 (85 tubes) were available for inspection.No fill volume defects (low fill) was observed in 85/85 retention tubes.Microbial growth was not observed in the retention tubes.For investigation of this complaint, retention tubes were incubated at 20 to 25 degrees c (5 tubes) and 33 to 37 degrees c (5 tubes).At 7 days incubation, 0/10 tubes had microbial growth.One photo was received for investigation.The photo shows 11 tubes in a rack with variations in the fill volumes of the tubes, including tubes with significantly low media volumes.One of the tubes also has what appears to be microbial growth in the tube.The batch information on the tubes is not readable in the photo and no product labels are displayed for batch verification.Without batch verification, the photo cannot confirm the complaint.No return samples were received for investigation.This complaint cannot be confirmed for contamination or fill volume.Bd will continue to trend complaints for defects.

• 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: 18044678
• MDR Text Key: 327042059
• Report Number: 1119779-2023-01196
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: (01)30382902451229
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 03/06/2024

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: 3103446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/20/2024
• 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