MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD TUBE MGIT 25 EA; SYSTEM, BLOOD CULTURING

Catalog Number 245111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/28/2020

Event Type  Death  

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

The customer reported that while using bd tube mgit 25 ea they noticed possible contamination.A patient death was reported.No information given suggests that the patient death was related to the device used.

Manufacturer Narrative

The following fields were modified with corrections: d.1.Medical device brand name: bd tube mgit 25 ea.D.2.Medical device type of device: mdb; common device name: system, blood culturing.

Event Description

The customer reported that while using bd tube mgit 25 ea they noticed possible contamination.A patient death was reported.No information given suggests that the patient death was related to the device used.

Manufacturer Narrative

H.6.Investigation summary: this product is manufactured by re-hydrating 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.

Event Description

The customer reported that while using bd tube mgit 25 ea they noticed possible contamination.A patient death was reported.No information given suggests that the patient death was related to the device used.

• Brand Name: BD TUBE MGIT 25 EA
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10094180
• MDR Text Key: 192352988
• Report Number: 1119779-2020-00118
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382902451112
• UDI-Public: 00382902451112
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/18/2020
• Device Catalogue Number: 245111
• Device Lot Number: 9267730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 05/05/2020; 05/05/2020
• Supplement Dates FDA Received: 05/29/2020; 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death