MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP); SYSTEM, BLOOD CULTURING

Model Number	245113
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (100/sp) false negative results were obtained by the laboratory personnel.A subculture was used to confirm the results as false negatives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter "we have mgit customer that had an incident of fn.".
Additional 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 0267376 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch for performance.Retention samples from batch 0267376 (100 tubes) were available for inspection.No defects were observed in 100/100 retention samples.For investigation of this complaint, retention tubes were tested for growth support and antibiotic susceptibility of mycobacterium species per the standard performance protocol for material 245122 as listed in the certificate of analysis.Growth support and antibiotic susceptibility of all organisms tested in the retention tubes from batch 0267376 was satisfactory with positive results returned from the instrument within the expected times.One photo was received to assist with the investigation: the photo shows one tube.One tube appears to have white clumps towards the sensor of the tube.No product information can be seen from the photo provided.No returns were received to assist with the investigation.Retention sample testing for growth support and antibiotic susceptibility was satisfactory.Bd will continue to trend complaints for performance.This complaint cannot be confirmed.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (100/sp) false negative results were obtained by the laboratory personnel.A subculture was used to confirm the results as false negatives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter "we have mgit customer that had an incident of fn.".

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (100/SP)
• Common Device Name: 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: 12334512
• Report Number: 1119779-2021-01402
• Device Sequence Number: 14697569
• Product Code: MDB
• UDI-Device Identifier: 30382902451137
• UDI-Public: 30382902451137
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K954932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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
• Operator of Device: Other
• Device Model Number: 245113
• Device Catalogue Number: 245113
• Device Lot Number: 0267376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown