BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEPICC

    MDR report key: 8313061 · Received February 6, 2019

    Report

    Report Number
    2032582-2016-00012
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    May 10, 2016
    Report Date
    February 6, 2019
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJS
    UDI-DI
    00813623013728
    PMA / PMN Number
    K083873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED ON THE PICC PRODUCT SINCE IT WAS NOT RETURNED TO PFM MEDICAL, INC. THERE IS NOT ENOUGH INFORMATION TO CONFIRM OR DENY THAT THE PICC PRODUCT WAS USED AS PER THE IFU. GIVEN THE SIMILARITY TO ANOTHER COMPLAINT, (B)(4), IT IS POSSIBLE THAT THE FAILURE WAS INDUCED BY EXCESSIVE FORCE BEING APPLIED TO THE HUB WHEN THE NURSE AND/OR PHYSICIAN WAS CONNECTING OR DISCONNECTING THE NEEDLE FREE VALVE, SYRINGE OR OTHER DEVICE. WITHOUT ACCESS TO THE PICC PRODUCT, HOWEVER, PFM MEDICAL WAS UNABLE TO CONFIRM THE ROOT CAUSE FOR THE CRACKED AND LEAKING HUB. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS OR DISCREPANCIES ASSOCIATED WITH LOT 1604-033. A NONCONFORMANCE REPORT REVIEW DETERMINED THAT THERE ARE NO OPEN OR CLOSED NCR'S FOR THE LOT IN QUESTION. COMPLAINT RECORDS WERE REVIEWED, AND A SIMILAR COMPLAINT DATING BACK TO (B)(6) 2012 WAS IDENTIFIED IN (B)(4). THE FAILURE MODE IN QUESTION IS ALREADY CAPTURED IN THE PICC DESIGN FMEA, FMEA (B)(4). (B)(4). NO CORRECTIVE OR PREVENTATIVE ACTION IS RECOMMENDED AT THIS TIME, AND PFM MEDICAL WILL CONTINUE TO MONITOR FOR INCIDENTS WITH SIMILAR FAILURE MODES.

    Description of Event or Problem · 1

    PICC CRACKED AND LEAKING. REPLACED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105510 PRIMEPICC PICC LJS PFM MEDICAL, INC. PFM2CT5D 1604-033 00813623013728

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention