BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASIC

    MDR report key: 17764470 · Received September 18, 2023

    Report

    Report Number
    3006260740-2023-04145
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 29, 2023
    Report Date
    January 22, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    DQY
    UDI-DI
    00801741035296
    PMA / PMN Number
    K871080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON.

    Additional Manufacturer Narrative · 0

    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. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAK IS INCONCLUSIVE DUE TO THE LACK OF DETAIL IN THE RETURNED VIDEO. ONE VIDEO OF A GROSHONG CATHETER WAS RETURNED FOR EVALUATION. REVIEW OF THE VIDEO FOUND THAT NO DAMAGE WAS PRESENT ON THE CATHETER. A SUBSTANCE, LIKELY A BEAD OF LIQUID, WAS PRESENT ON THE SURFACE OF THE CATHETER. THE LIQUID IS PRESENT ON THE CATHETER AT THE START OF THE VIDEO AND THROUGHOUT THE VIDEO NO LEAK CAN BE OBSERVED. THEREFORE, IT CANNOT BE DETERMINED IF THE LIQUID OBSERVED ORIGINATED FROM A CATHETER LEAK. INSUFFICIENT EVIDENCE WAS FOUND TO IDENTIFY THE ALLEGED ISSUE OR A ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE GROSHONG PICC PLACED FROM THE LEFT BASILIC VEIN AT THIS HOSPITAL IN (B)(6) 2023. 36 CM OF THE CATHETER WAS INSERTED INTERNALLY. THE PATIENT WAS IN ICU. ON (B)(6) 29, WHEN FLUSHING AND LOCKING THE CATHETER, THE NURSE FOUND SEEPAGE. WITH THE GUIDANCE OF A PICC SPECIALIST, THE CATHETER WAS PULLED OUT BY 2 CM FOR CATHETER RE-FLUSHING AND LOCKING. DURING THE PROCESS, DROPS OF LIQUIDS WERE FOUND AT THE SCALE OF 35 CM -36CM. IT WAS JUDGED THAT THE CATHETER WAS FRACTURED. THE NURSE THEN RE-TRIMMED THE CATHETER AND REPLACED THE EXTENSION TUBING TO CONTINUE THE USE OF THE CATHETER. NO OTHER ADVERSE REACTIONS AND SYMPTOMS WERE DEVELOPED IN THE PATIENT FOR THE TIME BEING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE GROSHONG PICC PLACED FROM THE LEFT BASILIC VEIN AT THIS HOSPITAL IN (B)(6) 2023. 36 CM OF THE CATHETER WAS INSERTED INTERNALLY. THE PATIENT WAS IN ICU. ON AUGUST 29, WHEN FLUSHING AND LOCKING THE CATHETER, THE NURSE FOUND SEEPAGE. WITH THE GUIDANCE OF A PICC SPECIALIST, THE CATHETER WAS PULLED OUT BY 2 CM FOR CATHETER RE-FLUSHING AND LOCKING. DURING THE PROCESS, DROPS OF LIQUIDS WERE FOUND AT THE SCALE OF 35 CM -36CM. IT WAS JUDGED THAT THE CATHETER WAS FRACTURED. THE NURSE THEN RE-TRIMMED THE CATHETER AND REPLACED THE EXTENSION TUBING TO CONTINUE THE USE OF THE CATHETER. NO OTHER ADVERSE REACTIONS AND SYMPTOMS WERE DEVELOPED IN THE PATIENT FOR THE TIME BEING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040200 GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASIC CATHETER, PERCUTANEOUS DQY C.R. BARD, INC. (BASD) -3006260740 N/A REGT4259 00801741035296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other