BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 11269976 · Received February 2, 2021

    Report

    Report Number
    1911916-2021-00074
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    October 5, 2020
    Report Date
    January 27, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9240137, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-28. MEDICAL DEVICE LOT #: 9240226, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-28. MEDICAL DEVICE LOT #: 9029598, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-01-29. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 9240137. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 9240226. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 9029598. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THE STERILIZATION AND DOSIMETRY REPORT THE CUSTOMER ALLERGAN IS LOOKING FOR IS NOT PART OF THE DOCUMENTS WE PROVIDE. IT IS RECOMMENDED THAT THE CUSTOMER ALLERGEN WORKS WITH THEIR SUPPLIER VWR. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 160 BD LUER-LOK¿ TIP SYRINGES FROM LOT 9240137, 640 SYRINGES FROM LOT 9240226, AND 480 SYRINGES IN LOT 9029598 WERE MISSING THE CERTIFICATE OF STERILITY IN THEIR SHIPMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON INSPECTION OF THE MATERIALS LISTED ABOVE, THE QC TECHNICIANS OBSERVED THAT NO CERTIFICATE OF STERILITY WAS INCLUDED WITH THE SHIPMENTS. AFTER MULTIPLE REQUESTS WITH THE VENDOR, A CERTIFICATE OF STERILITY COULD NOT BE OBTAINED. THESE LOTS WILL FAIL FOR DOCUMENTATION REQUIREMENTS PER (B)(4), "CERTIFICATE OF STERILITY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162591 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 SEE SECTION H.10. 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1