MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ PLATE TSA 5PRCT SB 90MM; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 254087

Device Problem Contamination (1120)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

H6.Investigation summary: complaint history review: complaint history was reviewed, and similar complaints were identified for this product; however, a trend could not be identified.Batch history record (bhr) review: the bhr was reviewed.No deviations from the validated manufacturing processes were identified.Sample analysis: the retain samples were reviewed and no deviation was detected.Return samples were not provided; however, picture sample was shared showing contaminated plate.Evaluation results: this product is filled under aseptic conditions.Therefore, sterility of the finished product cannot be guaranteed.Unfortunately, a 100 % inspection level for sterility is not possible and sterility testing is carried out based on a representative sample.In consequence, occasional contamination cannot be prevented by 100%; although the contamination rate remains below the acceptance level.A definite root cause was not identified.Investigation conclusion: based on the internal investigation, this complaint can be confirmed for contamination.H3 other text : see h.10.

Event Description

It was reported that before using bd bbl¿ plate tsa 5prct sb 90mm 12 plates were found contaminated.The following information was provided by the initial reporter: contaminated product before using the plats, the customers had noticed 12 plats were contaminated.Inside the agar were some bacterial colonies.

• Brand Name: BD BBL¿ PLATE TSA 5PRCT SB 90MM
• Type of Device: CULTURE MEDIA, NON-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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17895051
• MDR Text Key: 325261477
• Report Number: 9680577-2023-00043
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902540879
• UDI-Public: (01)30382902540879
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: PREAMENDMENT
• 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: 10/04/2023

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: 10/23/2023
• Device Catalogue Number: 254087
• Device Lot Number: 3199997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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