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

Model Number 245122

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml is moldy.No patient impact reported.The following information was provided by the initial reporter: get mouldy.

Manufacturer Narrative

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 1356839 was satisfactory per internal procedures.Formulation, filling, torquing, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and no other complaints have been taken on batch.Retention samples from batch 1356839 (100 tubes) were available for inspection.No contamination defects were observed in 100/100 retention samples.Ten uninoculated retention tubes from batch 1356839 were placed into incubation to test for contamination.Five tubes were placed into a 20 to 25 degrees celsius incubator and five tubes were placed in a 33-to-37-degree celsius incubator for seven days.At seven days incubation, there were no traces of microbial growth in the 10/10 incubated retention tubes.Two photos were received to assist with the investigation: the first photo shows one tube from batch 1356839.The second photo shows one tube, there does appear to be fungal growth possibly mold in the media.No returns were received to assist with the investigation.The complaint can be confirmed based on the evidence provided by the photos.Notes risk management review indicates the potential risk of the defect reported was assessed as severity [s1], per [baltrmlmbactecmgitaph, rev [02], id [6.3].

Event Description

It was reported that bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml is moldy.No patient impact reported.The following information was provided by the initial reporter: get mouldy.

• 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: 15613263
• MDR Text Key: 307079040
• Report Number: 1119779-2022-01305
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/17/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1356839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1