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 Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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¿ plate tsa 5prct sb 90mm, fungi was observed on two plates.No patient impact was reported.The following information was provided by the initial reporter: "i observed today 2 plates with fungi on tsa plates.Lot number: 3108651.Expiration: 2023-07-26.".

Event Description

It was reported that while using bd bbl¿ plate tsa 5prct sb 90mm, fungi was observed on two plates.No patient impact was reported.The following information was provided by the initial reporter: "i observed today 2 plates with fungi on tsa plates.Lot number: 3108651.Expiration: 2023-07-26.".

Manufacturer Narrative

H.6.Investigation summary: event description: the customer reported contamination of a plate.Complaint history review: the complaints trends were reviewed, and no similar complaint was registered for this lot number.Thus, a trend was not identified.Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Sample analysis: the retain samples were reviewed and no deviation could be detected.Return samples were not provided; however, pictures samples were shared demonstrating a contamination.Evaluation results.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.Investigation conclusion based on the evaluation and the provided pictures, the complaint was confirmed for contamination.A definite root cause could not be determined.

• 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: 17343178
• MDR Text Key: 319514730
• Report Number: 9680577-2023-00035
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 07/21/2023

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: 07/26/2023
• Device Catalogue Number: 254087
• Device Lot Number: 3108651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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