BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 6721416 · Received July 18, 2017

    Report

    Report Number
    2245270-2017-00036
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 26, 2017
    Report Date
    September 7, 2017
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT AND RETURNED SAMPLE HAVE BEEN SUBMITTED TO VYGON (B)(4), WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. VYGON (B)(4) REPORTS THE FOLLOWING REGARDING THIS COMPLAINT. AS REPORTED THE CUSTOMER HAS HAD PROBLEMS DURING STYLET REMOVING AND THE STYLET CAME OUT OF THE Y-PIECE. AFTER 5 DAYS IN USE THE CATHETER BROKE AT THE HUB. UNFORTUNATELY, THE RETURNED SAMPLE WAS ACCIDENTLY DISCARDED AFTER THE DECONTAMINATION PROCESS AT VYGON AND PRIOR TO EVALUATION; HOWEVER, WE ASSUME THAT THE CATHETER WAS LEAKING AT THE WING. IT IS KNOWN THAT THE CUSTOMER USED CHLORAPREP WHICH IS ALCOHOL BASED. IT IS ESSENTIAL TO LET THE DISINFECTANT DRY COMPLETELY BEFORE THE CATHETER IS PLACED, AS ALCOHOL OR ORGANIC SOLVENTS CAN DAMAGE THE CATHETER MATERIAL (SEE WARNING IN PRODUCT'S IFU). AS THE CATHETER WORKED WELL FOR 5 DAYS AND EACH CATHETER IS FLOW AND LEAK TESTED BEFORE PACKAGING, A MANUFACTURING FAULT COULD BE EXCLUDED AS THE ROOT CAUSE. THIS IS FIRST COMPLAINT FOR THE BATCHES 5178961 AND 4204361 AND THE 3RD COMPLAINT FOR CODE 4G07126106. NO CORRECTIVE ACTION IS WARRANTED; HOWEVER, BOTH VYGON GERMANY AND VYGON USA HAVE ENTERED THIS INCIDENT INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO VYGON FOR EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    PICC WAS INSERTED ON JUNE 21 AND BROKE ON JUNE 26 AT THE HUB. DURING PLACEMENT, THE STYLET SEPARATED FROM THE HUB AND HAD TO BE REMOVED.

    Description of Event or Problem · 1

    PICC WAS INSERTED ON (B)(6) AND BROKE ON (B)(6) AT THE HUB. DURING PLACEMENT, THE STYLET SEPARATED FROM THE HUB

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503513 PREMICATH LONG TERM INTRAVASCULAR CATHETER, LJS VYGON GMBH 1261.306G 15B001B

    Patients

    Seq Age Sex Outcome Treatment
    1