BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 13771482 · Received March 15, 2022

    Report

    Report Number
    3002682307-2022-00090
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K102328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 20-APR-2022. H6: INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 211118. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TWO SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM; HOWEVER, THE RETURNED PRODUCTS WERE BRAUN NEEDLES, NOT BD PRODUCT. BASED ON THE RETURNED SAMPLES, NO BD RELATED DEFECT COULD BE IDENTIFIED AND FURTHER ACTION WAS NOT DETERMINED NECESSARY. IF BD SAMPLES OR A BD IDENTIFIED NEEDLE ISSUE HAS OCCURRED, OUR QUALITY TEAM WILL PERFORM A THOROUGH ANALYSIS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD¿ BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNAWARE IF BD NEEDLE OR CAP FROM BBRAUN VILE IS CAUSING FOREIGN BODY IN THE VILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD¿ BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNAWARE IF BD NEEDLE OR CAP FROM BBRAUN VILE IS CAUSING FOREIGN BODY IN THE VILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695453 BD¿ BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 211118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown