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

Catalog Number 254091

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/24/2022

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 with chloramphenicol deep fill the customer noticed a white colony on the chromagar candida plate, which identified as staphylococcus.In addition, they observed gram negative cocci in most of the plate they used.Patient samples were involved and maldi tof was used as a confirmatory test.Results were reported to the clinician but there was no negative impact to the patients as the laboratory fixed itself after they identified it was staphylococcus.The following information was provided by the initial reporter: the customer notice a white colony on the chromagar candida plate, which identified as staphylococcus.In addition, they observed gram negative cocci in most of the plate they used.

Event Description

It was reported that while using bd bbl¿ sabouraud dextrose agar with chloramphenicol deep fill the customer noticed a white colony on the chromagar candida plate, which identified as staphylococcus.In addition, they observed gram negative cocci in most of the plate they used.Patient samples were involved and maldi tof was used as a confirmatory test.Results were reported to the clinician but there was no negative impact to the patients as the laboratory fixed itself after they identified it was staphylococcus.The following information was provided by the initial reporter: the customer notice a white colony on the chromagar candida plate, which identified as staphylococcus.In addition, they observed gram negative cocci in most of the plate they used.

Manufacturer Narrative

H.6 investigation summary event description: it was reported that the plates would not show the expected performance.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.A picture sample documenting the reported issue was not provided.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.

• Brand Name: BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL
• Type of Device: CULTURE MEDIA, SELECTIVE AND 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: 15180279
• MDR Text Key: 305065797
• Report Number: 9680577-2022-00094
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: NA
• 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: 09/02/2022

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: 09/23/2022
• Device Catalogue Number: 254091
• Device Lot Number: 2172774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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