MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number 221788

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin, there was contamination of 17 tubes.No patient impact reported.The following information was provided by the initial reporter: "customer reports contamination of #221788 lot number 3019808.".

Event Description

It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin, there was contamination of 17 tubes.No patient impact reported.The following information was provided by the initial reporter: "customer reports contamination of #221788 lot number 3019808.".

Manufacturer Narrative

H.6.Investigation summary: material 221788 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 (bhr) review for batch 3019808 was satisfactory per internal procedures.Formulation, filling, torquing, and autoclaving processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and one other complaint has been taken on this batch.Retention samples from batch 3019808 (10 tubes) were available for inspection.No media defects were observed in 10/10 retention samples.No signs of turbidity were observed in 10/10 retention tubes.For further investigation, two uninoculated tubes were incubated.One tube was incubated at 33-37- degree celsius and one tube was incubated in at 20-25-degree celsius.At the seventh day of incubation there were no signs of microbial growth or change in the media overall appearance.Eleven photos were received to assist with the investigation: two photos show the label of a partial bd-100 pack carton from batch 3019808 (carton number 0414).Two photos show a partial tube (the cap cannot be seen).The focus was on the media.The media appears yellow with particles/hazy.Seven photos show partial tubes from batch 3019808.The media in the tubes shows yellow media with particles/hazy appearance.Returns were received to assist with the investigation.A 100-pack bd original carton from batch 3019808 (carton number 0401) was received with tapped sides.All 100/100 tubes received were from batch 3019808.The broth appearance of all 100/100 returned tubes was medium yellow with particles/hazy appearance.All 100/100 returned tubes were incubated at 33-37-degrees celsius.At seven-days of incubation there was no change in the media appearance the media still appeared hazy with particles.Two returned tubes were boiled as stated in the ifu, and the media cleared to a medium yellow as described in the certificate of analysis.The following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 21-july-2023.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17375227
• MDR Text Key: 319709310
• Report Number: 1119779-2023-00795
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902217887
• UDI-Public: 30382902217887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803023
• 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: 10/19/2023

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: 01/20/2024
• Device Model Number: 221788
• Device Catalogue Number: 221788
• Device Lot Number: 3019808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1