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

Model Number 245122

Device Problem Break (1069)

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported that during use with the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, 2 tubes broke and the user was exposed to the patient sample inside.There was no impact to the user as they were wearing ppe.The following information was provided by the initial reporter: the tube was being removed from the instrument due to a negative status.When removed a crack was noticed and the liquid volume was low.They noted this is the second tube from this lot to do this.Have we had other complaints from this lot? do we have information on the shatter potential of these glass vials? no exposure to infectious substance as customer was using complete ppe.

Manufacturer Narrative

Initial reporter facility name: monash (b)(6) intensive care a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

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 1204332 was satisfactory per internal procedures.Filling, torqueing, and packaging processes were within specifications.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 for broken/cracked tubes.Retention samples from batch 1204332 (100 tubes) were available for inspection.There were no broken or cracked tubes observed in 100/100 retention samples.One photo was received to assist with the investigation: the photo shows one tube from batch 1204332 inside of a plastic bag.There is a crack towards the sensor of the tube.No returns were received to assist with the investigation.This complaint can be confirmed based on the evidence provided by the photo received.No actions are indicated at this time, 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 [s3], per [baltrmlmbactecmgitaph], rev [03], id [9.0].

Event Description

It was reported that during use with the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, 2 tubes broke and the user was exposed to the patient sample inside.There was no impact to the user as they were wearing ppe.The following information was provided by the initial reporter: the tube was being removed from the instrument due to a negative status.When removed a crack was noticed and the liquid volume was low.They noted this is the second tube from this lot to do this.Have we had other complaints from this lot? do we have information on the shatter potential of these glass vials? no exposure to infectious substance as customer was using complete ppe.

• 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: 14720948
• MDR Text Key: 303063404
• Report Number: 1119779-2022-00887
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/15/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1204332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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