BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 18722646 · Received February 16, 2024

    Report

    Report Number
    9617032-2024-00204
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    February 1, 2024
    Report Date
    May 16, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643146
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). E1. INITIAL REPORTER FACILITY NAME: (B)(6). H.6. INVESTIGATION SUMMARY: MATERIAL #: 364314 LOT/BATCH #: 3122762 BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO A CORRECTION: B3: DATE OF EVENT: 01-FEB-2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE CANNULA WAS STAINED. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE CANNULA WAS STAINED. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509094 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3122762 50382903643146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown