MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

Catalog Number 254089

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

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

It was reported that there have been several occurrences of bd bbl¿ gc ii agar with isovitalex¿ enrichment biological contamination has been found.The following information was provided by the initial reporter: we have problems from time to time with contamination by a filamentous element on your agars (the agars are already contaminated when we take them out of the closed bags and boxes).

Manufacturer Narrative

Investigation summary:event description: the customer reported problems from time to time with contamination by a filamentous element on our agars.Complaint history review: complaint history was reviewed, and similar complaints were identified for this catalog number.However, no trend was identified.Batch history record (bhr) review: the batch history record could not be reviewed, because there was no specific lot number.Sample analysis: retain samples could not be reviewed, because there was no specific lot number.Neither picture nor return samples were provided.Evaluation results: after investigations, no deviation could be detected in our validated manufacturing process.Since neither a specific lot number, nor pictures or returns were provided, no further investigations could be performed.Investigation conclusion: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.This product does not have an sal (sterility assurance level) claim.It is filled aseptically; therefore, an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed 4.9%.Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high-quality standard, we only release product batches to the market with an aql (acceptable quality level) = 0,65.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.Based on the above-mentioned evaluation, the complaint cannot be confirmed.Bd regrets the inconveniences you experienced and will continue to monitor similar incoming complaints.

• Brand Name: BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16751039
• MDR Text Key: 313404229
• Report Number: 9680577-2023-00013
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K945569
• 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
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/27/2023
• Device Catalogue Number: 254089
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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