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 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1174698.Medical device expiration date: 2022-12-17.Device manufacture date: 2021-06-23.Medical device lot #: 1204331.Medical device expiration date: 2023-01-15.Device manufacture date: 2021-07-23.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 2 bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml were contaminated, leading to false positive results for methylobacterium.Confirmatory subculture testing was performed and the result was negative.One erroneous result was reported out, but there was no report of patient impact.The following information was provided by the initial reporter: customer has had several tubes that flagged as positive.Upon subculture, the solid media grew methylobacterium.Organism is not growing on the original solid media (7h11/7h11s biplate).All of the specimens growing this are tissue or fluid specimens, that have not been decontaminated.

Event Description

It was reported that 2 bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml were contaminated, leading to false positive results for methylobacterium.Confirmatory subculture testing was performed and the result was negative.One erroneous result was reported out, but there was no report of patient impact.The following information was provided by the initial reporter: customer has had several tubes that flagged as positive.Upon subculture, the solid media grew methylobacterium.Organism is not growing on the original solid media (7h11/7h11s biplate).All of the specimens growing this are tissue or fluid specimens, that have not been decontaminated.

Manufacturer Narrative

H6 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.Batch 1204331.The batch history record review for batch 1204331 was satisfactory per internal procedures.And no quality notifications were generated during manufacturing and inspection.Formulation and filling processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.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 complaint has been taken on batch for contamination.Retention samples from batch 1204331 (100 tubes) were available for inspection.No media defects were observed in 100 retention samples.Ten uninoculated retention tubes from batch 1204331 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 incubated tubes and under uv light the incubated tubes did not show any increased fluorescence to indicate microbial growth.Batch 1174698.The batch history record review for batch 1174698 was satisfactory per internal procedures.And no quality notifications were generated during manufacturing and inspection.Formulation and filling processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.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 1174698.Retention samples from batch 1174698 (100 tubes) were available for inspection.No media defects were observed in 100/100 retention samples.Ten uninoculated retention tubes from batch 1174698 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 incubated tubes and under uv light the incubated tubes did not show any increased fluorescence to indicate microbial growth.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 contamination.

• 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: 13029127
• MDR Text Key: 287815808
• Report Number: 1119779-2021-01992
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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