BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2245270-2016-00020

    MDR report key: 5576206 · Received April 14, 2016

    Report

    Report Number
    2245270-2016-00020
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Date of Event
    March 3, 2016
    Report Date
    June 10, 2016
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OCCURRENCES OF THIS MALFUNCTION WERE REPORTED TO VYGON, THE DETAILS OF THE OTHER CAN BE FOUND IN MDR 2245270-2016-00019. AFTER A LIMITED INVESTIGATION INTO THIS CLAIM, VYGON (B)(4), (THE MANUFACTURER OF THIS PRODUCT), CANNOT CONFIRM A QUALITY PROBLEM WITH THIS PRODUCT DUE TO THE ABSENCE OF THE DEFECTIVE DEVISE FOR EVALUATION. HOWEVER, VYGON (B)(4) REPORTS THE FOLLOWING IN REGARDS TO THIS COMPLAINT: AFTER A REVIEW OF THE LOT HISTORY RECORDS, NO ABNORMALITIES WERE FOUND DURING THE BUILD OF THIS PRODUCT LOT, AND THIS IS THE FIRST COMPLAINT RECEIVED AGAINST IT. IT IS NOT KNOWN HOW LONG THE CATHETER HAD BEEN IN USE OR IF ANY ALCOHOL BASED DISINFECTANTS WERE IN CONTACT WITH THE CATHETER. NOTE: IT IS ESSENTIAL TO LET THE DISINFECTANT DRY COMPLETELY BEFORE THE CATHETER IS PLACED, AS ALCOHOL OR ORGANIC SOLVENTS CAN DAMAGE THE CATHETER MATERIAL. DUE TO THE FACT THAT EACH CATHETER IS LEAK AND FLOW TESTED BEFORE PACKAGING, A MANUFACTURING DEFECT SEEMS TO BE UNLIKELY. CORRECTIVE ACTION: NO CORRECTIVE ACTION HAS BEEN INITIATED AT THIS POINT IN TIME. HOWEVER, BOTH VYGON GERMANY AND VYGON USA HAVE ENTERED THIS INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Additional Manufacturer Narrative · 1

    TWO OCCURRENCES OF THIS MALFUNCTION WERE REPORTED TO VYGON, THE DETAILS OF THE OTHER CAN BE FOUND IN MDR 2245270-2016-00019. WHILE THIS DEVICE WAS NOT RETURNED TO VYGON, THE DETAILS OF THE MALFUNCTION HAVE BEEN FORWARDED TO THE MANUFACTURER FOR COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    DESPITE DRESSING BEING INTACT, THE CATHETER SNAPPED WHERE HUB HEART MEETS THE CATHETER. NO HARM NOTED, BUT NEW PICC LINE PLACED.

    Description of Event or Problem · 1

    DESPITE DRESSING BEING INTACT, THE CATHETER SNAPPED WHERE HUB HEART MEETS THE CATHETER. NO HARM NOTED, BUT NEW PICC LINE PLACED.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 DA