MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (25/SP); SYSTEM, BLOOD CULTURING

Catalog Number	245111
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (25/sp) reported positives for m.Kansasii for 4 patients.Additional specimens were collected on 2 different patients, and the second specimens resulted in no growth.The customer did not respond to requests for additional information.Therefore, it is unknown if these results were erroneous and it is unknown if they were reported out.
Event or Problem Description
It was reported that bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 4ml (25/sp) reported positives for m.Kansasii for 4 patients.Additional specimens were collected on 2 different patients, and the second specimens resulted in no growth.The customer did not respond to requests for additional information.Therefore, it is unknown if these results were erroneous and it is unknown if they were reported out.
Additional Manufacturer Narrative
H.6.Investigation summary this product 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 9267730 was satisfactory and no notifications were generated during manufacturing and inspection.Formulation and filling processes were within specifications.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 the only other complaint taken on this batch was also from this customer for contamination.Retention samples from batch 9267730 (100 tubes) were available for inspection.One tube had a loose cap but no other cap, tube or media defects were observed in the other 99 retention tubes.M.Kansasii atcc 12478 is one of the organisms tested in the standard performance protocol for material 245111.During qc testing of batch 9267730, atcc 12478 had satisfactory growth within the specification of 11 days incubation at 36 to 38 degrees.For investigation, retention tubes from batch 9267730 were incubated at 33 to 37 degrees c (10 tubes) and 36 to 38 degrees c (10 tubes).No microbial growth or changes were observed in 20/20 retention tubes at 13 days incubation.No returns or photos were received for investigation.Bd will continue to trend complaints for contamination.This complaint cannot be confirmed.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 4ML (25/SP)
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10114920
• Report Number: 1119779-2020-00125
• Device Sequence Number: 2405532
• Product Code: MDB
• UDI-Device Identifier: 00382902451112
• UDI-Public: 00382902451112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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 Expiration Date: 09/18/2020
• Device Catalogue Number: 245111
• Device Lot Number: 9267730
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other