MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ PLATE TSA W/LEC AND POLY80 RODAC

Catalog Number 254038

Device Problem Contamination (1120)

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

Event Date 03/14/2022

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 while testing with bd bbl¿ plate tsa w/lec and poly80 rodac biological contamination was observed.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: plates are positive.After consultation with the customer, it is about 10 plates, which are contaminated.

Manufacturer Narrative

Event description: the customer complained about 10 plates, which are contaminated.Complaint history review: the complaint history was reviewed for the past 12 months.Similar complaint were recorded for this catalog number during this period; however no trend was 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.Pictures were provided showing the reported contamination.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal 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 %.For our continuous monitoring, we derive a contamination ratio for below this specified value.According to our high quality standard, we only release product batches to the market with an aql (acceptable quality level) = (b)(4).Although this contamination level is very low, we cannot completely exclude that a customer may receive a contaminated plate.Investigation conclusion: although the shared pictures are not showing the involved batch number, bd recognizes this product as a bd media plate.Therefore, the complaint can be confirmed based on the shared pictures of the defect.A corrective and preventive action will not be implemented as a trend could not be identified.A definite root cause could not be determined.However bd will continue monitoring incoming similar complaints.

Event Description

It was reported while testing with bd bbl¿ plate tsa w/lec and poly80 rodac biological contamination was observed.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: plates are positive.After consultation with the customer, it is about 10 plates, which are contaminated.

• Brand Name: BD BBL¿ PLATE TSA W/LEC AND POLY80 RODAC
• Type of Device: NA
• 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: 14054819
• MDR Text Key: 298570102
• Report Number: 9680577-2022-00051
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/26/2022

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: 05/05/2022
• Device Catalogue Number: 254038
• Device Lot Number: 2026115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 06/26/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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