MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ SCHAEDLER AGAR WITH VITAMIN K1 AND 5% SHEEP BLOOD; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	254102
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while using bd bbl¿ schaedler agar with vitamin k1 and 5% sheep blood biological contamination was observed by the laboratory personnel.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: "agar was found contaminated.".
Additional Manufacturer Narrative
Investigation summary.It was reported a plate being affected by contamination.The complaint history has been reviewed for a period of 12 months and no similar issue was registered for this complained batch number.The batch history review did not indicate any discrepancies.All release testing was satisfactory and no deviations were observed.The retain samples were reviewed and no deviation could be detected.Neither return samples nor pictures illustrating the issue were shared.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) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.Based on the above mentioned evaluation and since neither pictures nor samples were provided to run the analysis, the complaint was not confirmed for contamination.
Event or Problem Description
It was reported that while using bd bbl¿ schaedler agar with vitamin k1 and 5% sheep blood biological contamination was observed by the laboratory personnel.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: "agar was found contaminated.".

• Brand Name: BD BBL¿ SCHAEDLER AGAR WITH VITAMIN K1 AND 5% SHEEP BLOOD
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13339115
• Report Number: 9680577-2022-00013
• Device Sequence Number: 14478221
• Product Code: JSG
• UDI-Device Identifier: 10382902541025
• UDI-Public: 10382902541025
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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
• Operator of Device: Other
• Device Expiration Date: 01/24/2022
• Device Model Number: 254102
• Device Catalogue Number: 254042
• Device Lot Number: 1306914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 05/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown