MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 254041

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/01/2022

Event Type  malfunction  

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 bd bbl¿ sabouraud dextrose agar w chloramphenicol & gentamicin deep fill there was excessive growth found.This is a report of a single occurrence.No false results were reported out to the clinician or the patient.The following information was provided by the initial reporter: "i am writing to report that a non conformity was found with sabouraud dextrose agar + gentamycin agar medium product code.020978 (ref 254041) lot #2150314 expires on 01/09/2022.Several platelets are not found to be selective for mycetes, since there has been growth, sometimes substantial growth, of gram negative bacteria on them.I kindly request that the received packages be replaced.Additional information from task: we were able to establish non-conformities when seeding biological samples from patients admitted to the o.U.Of our hospital.We did not report anything to the clinicians because the appearance of the colonies was compatible with the growth of gram-negative bacteria, rather than mycetes (in the case of sabouraud) or gram-positive bacteria (in the case of cna).".

Manufacturer Narrative

H.6.Investigation summary: event description: it was reported that several plates would not be selective.Complaint history review: the complaint history has been reviewed and for this product, several complaints were reported for a performance issue.Therefore, a trend was identified, and further investigation was performed.Batch history record (bhr) review: the batch history has been reviewed.It was identified that the chloramphenicol containing in this product was probably affected and further finished products were identified.Sample analysis: a performance test has been conducted on the retain samples of the complained batch 2150314.The results showed not deviation; however while testing other batches containing chloramphenicol, the performance issue could be confirmed.Return samples were not provided; however, pictures were shared showing growth on plates.Evaluation results and investigation conclusion: based upon our investigation, we have excluded any systematic failure in our manufacturing process.All the release testing was satisfactory and also the retest performed on the retain samples of the complained batch 2150314 did not reveal any deviation to the requirement.However while testing other batches containing chloramphenicol, the performance issue could be confirmed for excessive growth.Bd has identified an outside supplier issue with this plate¿s impregnated antibiotic, chloramphenicol, which results in a reduction in the antibacterial activity of the chloramphenicol over the shelf life of the agar.As a result a product recall has been initiated for the affected lots in the affected regions.Based on the above mentioned evaluation, this complaint was confirmed.Bd regrets the inconveniences you have been experiencing due to this issue and bd will continue monitoring incoming complaint with similar failure mode.H3 other text : see h.10.

Event Description

It was reported that while using bd bbl¿ sabouraud dextrose agar w chloramphenicol & gentamicin deep fill there was excessive growth found.This is a report of a single occurrence.No false results were reported out to the clinician or the patient.The following information was provided by the initial reporter: "i am writing to report that a non conformity was found with sabouraud dextrose agar + gentamycin agar medium product code.020978 (ref 254041) lot #2150314 expires on 01/09/2022.Several platelets are not found to be selective for mycetes, since there has been growth, sometimes substantial growth, of gram negative bacteria on them.I kindly request that the received packages be replaced.Additional information from task: 1) we were able to establish non-conformities when seeding biological samples from patients admitted to the o.U.Of our hospital.2) we did not report anything to the clinicians because the appearance of the colonies was compatible with the growth of gram-negative bacteria, rather than mycetes (in the case of sabouraud) or gram-positive bacteria (in the case of cna).".

• Brand Name: BD BBL¿ SABOURAUD DEXTROSE AGAR W CHLORAMPHENICOL & GENTAMICIN DEEP FILL
• Type of Device: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15115605
• MDR Text Key: 304698446
• Report Number: 9680577-2022-00084
• Device Sequence Number: 1
• Product Code: JSJ
• UDI-Device Identifier: 03829025404110
• UDI-Public: 3829025404110
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 254041
• Device Lot Number: 2150314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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