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 10/26/2021

Event Type  malfunction  

Event Description

It was reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml experienced bottle damage containing the patient sample.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: broken empty vial flagged positive.Result not provided to provider or posted on patient chart.Customer reporting mgit tube broke within instrument.

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 the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml experienced bottle damage containing the patient sample.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: broken empty vial flagged positive.Result not provided to provider or posted on patient chart.Customer reporting mgit tube broke within instrument.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11-nov-2021.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.Formulation, filling, and autoclaving processes were within specifications.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 only four complaints have been confirmed for broken/cracked tubes.Retention samples from batch 1204331 were available for inspection.No defects were observed in 100/100 retention samples.The retentions were performance tested for growth and susceptibility.All performance testing was satisfactory per procedures.No photos were received to assist with the investigation.Returns were received to assist with the investigation.A shipping box was received with two bd cartons from batch 1204331.There were one-hundred and forty tubes received.Twenty tubes were received broken.Returns were also performance tested for growth and susceptibility.All performance testing was satisfactory per procedure.This complaint can be confirmed for broken tubes based on the returns.This complaint cannot be confirmed for performance.The bd engineering team identified several areas for improvement for the manufacturing of the 245122 bactec mgit 7ml tubes.Improvement projects have been completed.Bd will continue to trend complaints for broken tubes and performance.

Event Description

It was reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml experienced bottle damage containing the patient sample.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: broken empty vial flagged positive.Result not provided to provider or posted on patient chart.Customer reporting mgit tube broke within instrument.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12902242
• MDR Text Key: 286066632
• Report Number: 1119779-2021-01895
• 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: 05/11/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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