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 02/24/2022

Event Type  malfunction  

Event Description

It was reported that 100 bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin media bottles had liquid contamination found in them before use.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "customer is reporting contamination on lot 1147890"."how many samples had observable contamination? entire box, 100 tubes.Describe: even/uneven turbidity? surface/subsurface/cloudy (liquid) particles throughout.When was the contamination observed? before or after inoculation/incubation? before or after opening sleeve? when opened, not inoculated or incubated.Were contaminants identified? no".

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 100 bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin media bottles had liquid contamination found in them before use.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "customer is reporting contamination on lot 1147890".How many samples had observable contamination? entire box, 100 tubes describe: even/uneven turbidity? surface/subsurface/cloudy (liquid) particles throughout.When was the contamination observed? before or after inoculation/incubation? before or after opening sleeve? when opened, not inoculated or incubated were contaminants identified? no".

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 review for batch 1147890 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, torquing, and autoclaving 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 no other complaints have been taken on this batch.Retention samples from batch 1147890 (10 tubes) were available for inspection.No contamination observations in 10/10 retention samples were observed in the media, however the media did appear hazy.For further investigation, two uninoculated tubes for turbidity and contamination one tube was incubated at 33-37- degree celsius and one tube was incubated in at 20-25- degree celsius both tubes showed no signs of microbial growth within seven days of incubation and no change in the appearance of the media.For further investigation, of color and clarity per procedure for material 221788 one tube was also boiled for ten minutes the media cleared to a medium clear yellow as described in the certificate of analysis.Three photos were received to assist with the investigation: first photo shows a partial opened carton seventeen tubes can be partially seen.Two tubes were partial pulled from the carton the media does appear hazy.No product information was presented in this photo.The second photo also shows a partial opened carton.Twenty-four tubes can partially be seen.Two tubes were pulled from the rack in the carton the media does appear to be hazy.No product information is present in this photo.The third photo shows the caps on three tubes inside of a plastic bag.One of the caps appears to have possibly mold on the cap.No product information is presented in the photo.Without product information a photo alone cannot confirm a complaint.A photo must provide a clear indication of the product, product defect, and important product information such as batch/lot number must be provided in the photo.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination/foreign material.Also, per procedure, for material 221788 prior to use the material is to be boiled for 10 mins.Notes risk management review indicates the potential risk of the defect reported was assessed as severity [s1], per [baltrmterminalgpaph ], rev [04], id [4.1].

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13792136
• MDR Text Key: 292512434
• Report Number: 1119779-2022-00441
• 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: 09/09/2022

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: 05/20/2022
• Device Model Number: 221788
• Device Catalogue Number: 221788
• Device Lot Number: 1147890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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