BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUB SPIN-LOC THREADED LOCKING OEM

    MDR report key: 11646110 · Received April 9, 2021

    Report

    Report Number
    2243072-2021-01070
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 14, 2021
    Report Date
    April 27, 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

    H.6. INVESTIGATION: DUE THE LOT NUMBER WAS NOT PROVIDED; IT WAS NOT POSSIBLE TO PERFORM THE DHR REVIEW. ONE SAMPLE FROM MODEL 2013-280-022 WAS RECEIVED BY TJ INVESTIGATOR. IT WAS REPORTED BY CRACK 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. NEVERTHELESS, AFTER A VISUAL INSPECTION NO CRACKS WERE FOUND IN SAMPLE RECEIVED. IN ADDITION, THE SAMPLE WAS ASSEMBLED, AND NO PROBLEMS WERE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HUB SPIN-LOC THREADED LOCKING OEM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2013-280-022 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THERE IS LEAKAGE AFTER THE IV HAS BEEN STARTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HUB SPIN-LOC THREADED LOCKING OEM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2013-280-022, BATCH NO: UNKNOWN. IT WAS REPORTED THAT THERE IS LEAKAGE AFTER THE IV HAS BEEN STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542789 HUB SPIN-LOC THREADED LOCKING OEM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1