BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEPICC

    MDR report key: 14788259 · Received June 23, 2022

    Report

    Report Number
    2032582-2022-00005
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 1, 2022
    Report Date
    June 23, 2022
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    LJS
    PMA / PMN Number
    K072391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE DEVICE HISTORY RECORD REVIEW WAS NOT BE ABLE TO PERFORMED AS THE LOT NUMBER IS UNKNOWN. REVIEW OF RECORDED COMPLAINTS ON THE LAST THREE YEARS (2019 -2021): 8 SIMILAR COMPLAINTS WERE RECORDED ON DIFFERENT LOT NUMBER. TOTAL SALES OF PRIMEPICC PRODUCT FOR (2019-2021): (B)(4) UNITS. COMPLAINT RATE = (B)(4) OF THE SALES. REVIEW OF RISK ANALYSIS: RISK IS IDENTIFIED WITHIN THE RISK ANALYSIS AND IS A KNOWN RISK OF THE DEVICE. PROBABLE OCCURRENCE RATE OF (B)(4). RETURNED SAMPLE EVALUATION: THE COMPLAINT PRODUCT WAS RETURNED WITH BLOOD CONTAMINATION. HOWEVER, A VISUAL INSPECTION WAS CONDUCTED AND THE CRACK ON THE CLEAR LUER CONNECTOR WAS CONFIRMED (SEE ATTACHED PHOTOS). THE PURPLE LUER CONNECTOR DID NOT SHOW ANY SIGNS OF CRACKS. REVIEW OF THE SAME REFERENCE NUMBER: SINCE THE LOT NUMBER IS UNKNOWN, A REVIEW OF THE RETAINED SAMPLE AND TESTING RECORD FROM THE SAME REFERENCE NUMBER WAS PERFORMED AND NO DEVIATIONS WERE FOUND. THE CATHETER MET THE SPECIFICATION FOR ALL DESTRUCTIVE TESTING. LUMEN MAINTAINS 90PSIG FOR A MINIMUM OF 15 SECONDS WITHOUT LEAKS. THE TENSILE STRENGTH OF THE CONNECTIONS IS >=] 6 LBF. THE SUPPLIED VALVE CONNECTOR WAS ALSO CONNECTED MULTIPLE TIMES TO THE CATHETER AND A SUBSTANTIAL AMOUNT OF FORCE WAS APPLIED WITHOUT ANY ISSUES. CONCLUSION: THE ISSUE CAN BE ATTRIBUTED TO THE OVER-TIGHTENING OF THE CONNECTION DURING TREATMENT AS THE LUER CONNECTORS ARE DESIGNED TO SEAL WITH HAND TIGHTNESS. THE IFU INDICATES THAT REPEATED OVER-TIGHTENING OF THE LUER LOCK CONNECTION, SYRINGES, AND CAPS COULD LEAD TO POTENTIAL CONNECTOR FAILURE. IN ADDITION, CATHETER CONTACT WITH ALCOHOL, ACETONE, AND POLYETHYLENE GLYCOL-CONTAINING OINTMENTS MAY CAUSE THE FAILURE OF THE DEVICE. THE ISSUE IS IDENTIFIED WITHIN THE RISK ANALYSIS AND THE OCCURRENCE RATE IS BELOW THE ACCEPTABLE FREQUENCY RATE OF THE RISK ANALYSIS. THE ACTUAL ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. PFM MEDICAL, INC. WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    PRIMEPICC HUB (LUER CONNECTOR) CRACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329249 PRIMEPICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS PFM MEDICAL, INC. PFM2CT4DP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention