BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 16361647 · Received February 13, 2023

    Report

    Report Number
    2245270-2023-00008
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 21, 2023
    Report Date
    May 5, 2023
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THE CUSTOMER RETURNED A 30 CM LONG PREMICATH CATHETER INSTEAD OF 20 CM LENGTH CODE 1261.203G. THE USED SAMPLE ARRIVED IN THREE FRAGMENTS: THE FIRST FRAGMENT HAD A LENGTH OF 18.5 CM. THE FRACTURED PLANE AT ITS PROXIMAL END WAS ROUGH AND UNEVEN. THE SECOND FRAGMENT HAD A LENGTH OF 1 CM WITH THE 19 CM MARKING IN ITS MIDDLE PROXIMAL END. BOTH ENDS OF THIS FRAGMENT HAVE A ROUGH AND UNEVEN FRACTURED PLANE. THE LAST FRAGMENT FROM 19.5 CM TO ITS PROXIMAL END INCLUDING THE EXTENSION LINE ALSO SHOWED A ROUGH AND UNEVEN DISTAL FRACTURE PLANE. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED FOR BATCH NO. 8131568, 8134057, AND 8138681, AND NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH THEIR SPECIFICATIONS AND WERE RELEASED. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. NO SIMILAR COMPLAINTS REGARDING A SWOLLEN NECK AFTER CONTRAST INJECTION WERE EVER RECEIVED ON CODE 4G07126103. CORRECTIVE ACTION: AS THE CATHETER WORKED WELL FOR 10 DAYS BEFORE THE SWOLLEN NECK AFTER CONTRAST INJECTION OCCURRED, WE DO NOT BELIEVE THIS DEFECT WAS MANUFACTURING RELATED. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK/RUPTURE WOULD BE DETECTED BY THE USER WHEN FLUSHING THE CATHETER. ADDITIONALLY, THE PRODUCT INCIDENT REPORT MENTIONED THAT THERE WAS NO INDICATION THAT SOMETHING IS WRONG WITH THE PICC. THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS STILL IN DECONTAMINATION PROCESS AND HAS NOT BEEN RETURNED FOR EVALUATION. THE RESULTS OF THIS INVESTIGATION IS STILL PENDING.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 0

    INFILTRATION INTO BABY'S SVC. NO PUMP ALARM. NO INDICATION THAT SOMETHING WAS WRONG WITH THE PICC. THE INFILTRATION WAS FOUND AFTER CONTRAST WAS INJECTED INTO PICC AND INFANT'S NECK WAS NOTED TO BE SWOLLEN BILATERALLY

    Description of Event or Problem · 0

    INFILTRATION INTO BABY'S SVC. NO PUMP ALARM. NO INDICATION THAT SOMETHING WAS WRONG WITH THE PICC. THE INFILTRATION WAS FOUND AFTER CONTRAST WAS INJECTED INTO PICC AND INFANT'S NECK WAS NOTED TO BE SWOLLEN BILATERALLY.

    Description of Event or Problem · 0

    INFILTRATION INTO BABY'S SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721954 PREMICATH LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1261.203G 21D015D

    Patients

    Seq Age Sex Outcome Treatment
    1 42 DA Female