BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE LUER SLIP 64 CAV.

    MDR report key: 11530741 · Received March 19, 2021

    Report

    Report Number
    9616066-2021-50516
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    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 : 6 SAMPLES OF THE 1013-156-022 MODEL WERE RECEIVED A PRELIMINARY VISUAL INSPECTION WAS PERFORMED. DHR REVIEW COULD NOT BE COMPLETED DUE TO NO LOT NUMBER WAS REPORTED. SMALL CRACKS WERE IDENTIFIED IN ONLY 4 SAMPLES, NO ISSUES WERE DETECTED IN THE TWO REMAINING. SINCE THE FAILURE MODE COULD NOT BE REPLICATED, A CAUSE EFFECT WAS CONDUCTED, HOWEVER, SINCE THE DAMAGE IS IN THE OUTSIDE OF THE FLUID PATH, IT WAS CONSIDERED THAT AN EXTERNAL FORCE GENERATED THE DAMAGE, THEREFORE, THE ROOT CAUSE COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MALE LUER SLIP 64 CAV. EXPERIENCED A CASE OF LEAKAGE AND A CASE OF DEVICE DEFORMATION/DAMAGE/CRACKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 1013-156-022, BATCH NO: UNKNOWN. 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 MALE LUER SLIP 64 CAV. EXPERIENCED A CASE OF LEAKAGE AND A CASE OF DEVICE DEFORMATION/DAMAGE/CRACKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 1013-156-022. BATCH NO: UNKNOWN. 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
    429759 MALE LUER SLIP 64 CAV. LUER SLIP TIP FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1