BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN

    MDR report key: 12910447 · Received December 1, 2021

    Report

    Report Number
    3006260740-2021-05086
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    October 30, 2021
    Report Date
    January 13, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741047466
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING INFUSION SET WAS CONFIRMED AND THE CAUSE IS CURRENTLY UNDER INVESTIGATION. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 20GA X 0.75" POWERLOC MAX SAEFTY INFUSION SET. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND THE FOLLOWING OBSERVATIONS WERE MADE: THE FRACTURE SURFACES OF THE DAMAGE CONTAINED STRIATION-LIKE PATTERNS, TEAR PATTERNS AND BUCKLING WHICH WERE INDICATIVE OF FLEXURAL FATIGUE BASED MATERIAL FAILURE. WHILE REPETITIVE MECHANICAL STRESSES SUCH AS TWISTING AND KINKING MAY HAVE CONTRIBUTED TO THE OBSERVED EVENT, IT APPEARED THAT ADDITIONAL UNIDENTIFIED FACTORS ALSO CONTRIBUTED. THE DEVICE IS A SUPPLIED COMPONENT AND THE SUPPLIER HAS BEEN NOTIFIED OF THIS EVENT. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

    Description of Event or Problem · 0

    IT WAS REPORTED "AT APPROXIMATELY 1320 PATIENT'S LINE WAS FLUSHED AND POSITIVE BLOOD RETURN WAS PRESENT. APPROXIMATELY TEN MINUTES LATER, FAMILY CALLED AND BLOOD HAD LEAKED THROUGH THE DISTAL END OF THE TUBING ATTACHED TO THE NEEDLE JUST BEFORE THE CLAVE. THE RN CLAMPED THE TUBE AND FLUSHED NS THROUGH AND FOUND A HOLE/CRACK NEAR THE NEEDLESS CONNECTOR. THE RN THEN DE-ACCESSED AND RE-ACCESSED THE PORT." ORIGINALLY ACCESSED 10/24/21 @ 1415, SO 6 DAYS IN TOTAL NO OTHER TREATMENT NEEDED ASIDE FROM NEW NEEDLE WAS RUNNING NORMAL SALINE AT 3ML/HR WHEN LEAKING DISCOVERED NO INFILTRATION OR EXTRAVASATION NOTED

    Description of Event or Problem · 0

    IT WAS REPORTED "AT APPROXIMATELY 1320 PATIENT'S LINE WAS FLUSHED AND POSITIVE BLOOD RETURN WAS PRESENT. APPROXIMATELY TEN MINUTES LATER, FAMILY CALLED AND BLOOD HAD LEAKED THROUGH THE DISTAL END OF THE TUBING ATTACHED TO THE NEEDLE JUST BEFORE THE CLAVE. THE RN CLAMPED THE TUBE AND FLUSHED NS THROUGH AND FOUND A HOLE/CRACK NEAR THE NEEDLESS CONNECTOR. THE RN THEN DE-ACCESSED AND RE-ACCESSED THE PORT." ORIGINALLY ACCESSED (B)(6) 21 @ 1415, SO 6 DAYS IN TOTAL. NO OTHER TREATMENT NEEDED ASIDE FROM NEW NEEDLE. WAS RUNNING NORMAL SALINE AT 3ML/HR WHEN LEAKING DISCOVERED. NO INFILTRATION OR EXTRAVASATION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806465 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741047466

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Unknown Other