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

Model Number 245122

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

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, the tube cracked and patient sample leaked.The following information was provided by the initial reporter.The customer stated: when unloaded as a completed negative vial, it was noticed that ~6ml liquid was missing from the tube.Inspection revealed a crack in the tube.They have discarded the tube immediately due to health and safety risks, so unable to provide a photo.They did not perform a stain on the remaining liquid to confirm if there are organisms present.Sample was negative on the instrument, but an additional sample was positive, so it is assumed it is a false negative due to the crack/lost liquid.

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.The batch history record review for batch 1300510 was satisfactory per internal procedures.Filling and packaging processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures and checks for torque confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and one other complaint have been taken on this batch.Retention samples from batch 1300510 (100 tubes) were available for inspection.No broken/cracked tubes were observed in 100/100 retention samples.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed by the investigation of the retention samples and lack of photos and returns, however manufacturing records indicate that broken tubes were observed due to a mechanical defect during manufacturing.Repairs to the equipment were made and additional inspections were completed on this batch, however this does not guarantee no defects.This complaint is confirmed due to the mechanical defect identified during production of the batch.Bd will continue to trend complaints for broken/cracked tubes.Notes: risk management review indicates the potential risk of the defect reported was assessed as severity [s4], per [baltrmlmbactecmgitaph ], rev [03], id [10.0].H3 other text : see h.10.

Event Description

It was reported when using the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, the tube cracked and patient sample leaked.The following information was provided by the initial reporter.The customer stated: when unloaded as a completed negative vial, it was noticed that ~6ml liquid was missing from the tube.Inspection revealed a crack in the tube.They have discarded the tube immediately due to health and safety risks, so unable to provide a photo.They did not perform a stain on the remaining liquid to confirm if there are organisms present.Sample was negative on the instrument, but an additional sample was positive, so it is assumed it is a false negative due to the crack/lost liquid.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14973731
• MDR Text Key: 304511085
• Report Number: 1119779-2022-00977
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/23/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1300510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/10/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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
• Patient Outcome(s): Other