BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 11935497 · Received June 3, 2021

    Report

    Report Number
    1911916-2021-00512
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8250854, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: (B)(6) 2018. MEDICAL DEVICE LOT #: 8361988, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: (B)(6) 2018. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 8250854. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 8361988. 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. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. 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 3 NEEDLE FILTER BLUNT FILL 18X1-1/2 CONTAINED FOREIGN MATTER AND WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WHITE FOREIGN MATERIAL ON FILTER NEEDLE. THE CUSTOMER DESCRIBED THAT THIS MATERIAL SEEMS TO BE PART OF WHITE PAINT AND LOCATED AROUND THE LUER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826125 NEEDLE FILTER BLUNT FILL 18X1-1/2 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 SEE H.10. 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1