BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUB SPIN-LOC THREADED LOCKING OEM

    MDR report key: 11532585 · Received March 19, 2021

    Report

    Report Number
    2243072-2021-00846
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THREE SAMPLES FROM MODEL 2013-280-022 WERE RECEIVED BY TJ INVESTIGATOR. THE SAMPLES WERE REPORTED TO BE CRACKED AND THAT THE LUER LOCK HUB WAS NOT LOCKING INTO CATHETER CAUSING LEAKAGE, AND AN EXTENSION SET INSIDE A KIT HAS A COMPROMISE NEAR THE LL HUB. AFTER A VISUAL INSPECTION NO CRACKS WERE FOUND IN ANY OF THE 3 SAMPLES RECEIVED AND NO PROBLEMS WERE FOUND. IN ADDITION, THE SAMPLES WERE ASSEMBLED, AND NO PROBLEMS WERE IDENTIFIED. SINCE NO LOT WAS REPORTED, THE DHR WAS NOT PERFORMED, HOWEVER, THE 3 SAMPLES WERE ASSEMBLED AND REVIEWED VISUALLY AND BY TJ INVESTIGATOR TO CONFIRM THE FAILURE MODE AND NO DAMAGE OR CRACKS WERE FOUND. SINCE THE FAILURE MODE WAS NOT CONFIRMED, THE ROOT CAUSE COULD NOT BE DETERMINATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB SPIN-LOC THREADED LOCKING OEM LEAKED DURING USE AND DAMAGE WAS FOUND ON THE EXTENSION SET NEAR THE LL HUB. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. LUER LOCKING HUB NOT LOCKING INTO CATHETER CAUSING LEAKING. 2. EXTENSION SET INSIDE KIT HAS A COMPROMISE NEAR THE LL HUB.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB SPIN-LOC THREADED LOCKING OEM LEAKED DURING USE AND DAMAGE WAS FOUND ON THE EXTENSION SET NEAR THE LL HUB. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LUER LOCKING HUB NOT LOCKING INTO CATHETER CAUSING LEAKING. EXTENSION SET INSIDE KIT HAS A COMPROMISE NEAR THE LL HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419368 HUB SPIN-LOC THREADED LOCKING OEM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1