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

Catalog Number 221788

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 11/12/2023

Event Type  malfunction  

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.

Event Description

It was reported when using the bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin has been contaminated.There was no report of impact to patient or user.

Event Description

It was reported when using the bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin has been contaminated.There was no report of impact to patient or user.

Manufacturer Narrative

H.6.Investigation summary: the release testing that is performed on this product does include media appearance.No foreign objects were observed in qc samples at the time of release.If foreign matter had been noted during qc testing, the product would have been placed on quality notification and further analysis including 100% inspection of the batch would have been conducted.The complaint history was reviewed, and there is one other complaint on batch 3025456.Retention samples (10) were available for inspection.All ten of the retention samples appeared trace hazy with particles.Two of the retention samples were reduced by boiling and allowed to cool.After cooling, the particles were no longer visible in the solution.As stated in the ifu for material 221788 (available on bd.Com/e-labeling), this media should be reduced by boiling prior to use.The two reduced retention samples were then incubated in a 20-25 degree celsius incubator (1) and a 33-37 degree celsius incubator (1).At fourteen days, there was no growth observed in the incubated retention samples.No photos were received to assist in the investigation.Five tubes were returned from batch 3025456 in a zip lock bag with padding in a box with returns for another complaint.The five tubes contained small particles.The media was not hazy.After the five returned tubes were reduced by boiling and cooled, two of the tubes contained a few particles.The media was gram stained and showed no organisms.The five tubes were incubated in a 33-37 degree celsius incubator.At seven days, no growth was observed in any of the returned tubes.This complaint can be confirmed for particles.As stated in the ifu mentioned above, this media should be reduced by boiling prior to use.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for particles.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18307636
• MDR Text Key: 330935578
• Report Number: 1119779-2023-01337
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 00382902217886
• UDI-Public: (01)00382902217886
• 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,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: 01/27/2024
• Device Catalogue Number: 221788
• Device Lot Number: 3025456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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