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

Model Number 245122

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/21/2022

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 that 3 bd bbl¿ mgit¿ mycobacteria growth indicator tubes were found cracked and broken when removing them from the instrument.One of the tubes leaked out a patient sample positive for mtb, requiring decontamination of the instrument.There was no report of adverse patient or user impact.The following information was provided by the initial reporter: "customer was removing negative tubes, and noticed that 3 tubes were broken/cracked.2 of the tubes did not appear to leak, and those patients had no history of afb.1 tube leaked into the instrument, and that patient previously had a culture positive for mtb." "customer said ppe is worn at most times, in the room, but occasionally they take off their n95 masks.".

Event Description

It was reported that 3 bd bbl¿ mgit¿ mycobacteria growth indicator tubes were found cracked and broken when removing them from the instrument.One of the tubes leaked out a patient sample positive for mtb, requiring decontamination of the instrument.There was no report of adverse patient or user impact.The following information was provided by the initial reporter: "customer was removing negative tubes, and noticed that 3 tubes were broken/cracked.2 of the tubes did not appear to leak, and those patients had no history of afb.1 tube leaked into the instrument, and that patient previously had a culture positive for mtb." "customer said ppe is worn at most times, in the room, but occasionally they take off their n95 masks.".

Manufacturer Narrative

H.6.Investigation: 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 1204331 was satisfactory per internal procedures.Torquing 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 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 six other complaints have been taken on this batch for broken/cracked tubes.Retention samples from batch 1204331 (100 tubes) were available for inspection.No tube defects were observed in 100/100 retention samples.There was no evidence of broken and or cracked tubes from visual inspection of 100/100 retention tubes.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for broken/cracked tubes.H3 other text : see h.10.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
• 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: 13524540
• MDR Text Key: 289615777
• Report Number: 1119779-2022-00238
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

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 Expiration Date: 01/15/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1204331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 04/21/2022
• 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