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 /Decontamination Problem (2895)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin there was biological contamination.This occurred on twenty tubes.No erroneous results were passed on to the clinician.There was no patient impact.The following information was provided by the initial reporter: "the broth is turbid and gram-negative rods were detected in the gram preparation".

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: this complaint can be confirmed by the trend.The complaint history was reviewed, and two other complaints have been taken on this batch for contamination.Retention samples from batch 3011172 (10 tubes) were available for inspection.No contamination or turbidity was observed in 10/10 retention samples.For investigation, two retention tubes went into incubation.One tube was incubated in the 20-25 degrees celsius, and the other tube was placed in the 33¿37-degree celsius incubator.At 7 days incubation, no microbial growth or turbidity was observed in 2/2 incubated tubes.One photo was received to assist with the investigation.The photo shows two tubes, one from batch 3011172 and one tube from batch 2251073.The tube from batch 3011172 does appear to be hazy in clarity.No returns were received to assist with the investigation.The cause of the hazy media in the photo could not be identified from this investigation.However, bd has identified a complaint trend for hazy media due to the presence of non-viables for this product.A capa (corrective and preventative actions) has been initiated per bd procedures.The capa has completed execution of corrective actions.Bd expects improvement in the observation of hazy media due to non-viables as the capa progresses.Bd will continue to trend complaints for contamination/appearance (turbidity) defects.This complaint can be confirmed by the trend.

Event Description

It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin there was biological contamination.This occurred on twenty tubes.No erroneous results were passed on to the clinician.There was no patient impact.The following information was provided by the initial reporter: "the broth is turbid and gram-negative rods were detected in the gram preparation.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17148121
• MDR Text Key: 317757080
• Report Number: 1119779-2023-00672
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902217887
• UDI-Public: 30382902217887
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K803023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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: 01/09/2024
• Device Model Number: 221788
• Device Catalogue Number: 221788
• Device Lot Number: 3011172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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