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 Contamination (1120)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that while using 4 bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer problem: customer reports contamination on media tubes 221788 right out of the box.Lot#: 1244320.".

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

It was reported that while using 4 bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: customer problem: customer reports contamination on media tubes 221788 right out of the box.Lot#: 1244320.

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 1244320 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.The complaint history was reviewed, and one other complaint has been taken on this batch for contamination.Retention samples from batch 1244320 (10 tubes) were available for inspection.No media, defects were observed in 10/10 retention samples.For investigation two retention tubes went investigation.One retention tube went into 20¿25-degree celsius incubation.One retention tube went into 33-37-degree celsius.At the end of a seven-day incubation period there was no microbial growth in 2/2 retention tubes.Four photos were received to assist with the investigation: the first photo shows the label of a partial bd 100 pack carton from batch 1244320.The second photo also shows media from two partial tubes; the media does appear to have a hazy appearance.The third photo shows another angle of the media from two partial tubes; the media does appear to have a hazy appearance.The last photo shows two tubes.One tube is from batch 1238117 (ref pr (b)(4)) and one tube from batch 1244320.The media in both tubes does appear to be hazy.For appearance of the media, material 221788 procedure states to boil the tubes with loosened caps for ten minutes before use.For investigation purpose three return tubes and one retention tube were boiled the media appearance cleared up to a light/medium light yellow clear appearance as describe in the certificate of analysis.Returns were also received to assist with the investigation.A shipping box was received with four bd cartons from batch 1244320 carton numbers 0024, 0191, 0195, and 0166.There were 386 tubes received in overall good condition.The media did appear hazy.For investigation of complaint all four cartons went into incubation.One tube was plated on two tsa 5% sheep blood agar.One plate was placed in the 20-25-degrees celsius incubation and one plate was placed in 33-37-degree celsius incubation.There was no microbial growth on either plate after incubation.Two cartons were placed into 20-25-degrees celsius incubation.Two cartons were placed into 33-37-degrees celsius incubation.At the end of a seven-day incubation period there was no real change in the media after incubation.A gram stain was performed on one tube from batch 1244320, the gram stain revealed gram negative rods.This complaint can be confirmed for non-viables from the returns received.A trend has not been identified, therefore, no actions are planned at this time.

• 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: 13067817
• MDR Text Key: 284696199
• Report Number: 1119779-2021-02021
• 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: 06/30/2022

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: 08/30/2022
• Device Model Number: 221788
• Device Catalogue Number: 221788
• Device Lot Number: 1244320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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