BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN

    MDR report key: 9672205 · Received February 5, 2020

    Report

    Report Number
    3006260740-2020-00393
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 17, 2020
    Report Date
    June 17, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741047350
    PMA / PMN Number
    K153440
    Removal / Correction Number
    2243072-06/03/2020-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF ASDTF043 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MS&S, "CALLER STATES WHILE USING MULTIPLE POWERLOC MAX PRODUCTS (REFERENCE# 0132010, LOT# ASDTF043) THERE IS LEAKAGE AND/OR IT POPS OFF." NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF ASDTF043 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MS&S, "CALLER STATES WHILE USING MULTIPLE POWERLOC MAX PRODUCTS (REFERENCE# 0132010, LOT# ASDTF043) THERE IS LEAKAGE AND/OR IT POPS OFF." NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136872 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A ASDTF043 00801741047350

    Patients

    Seq Age Sex Outcome Treatment
    1