BEUDAMED
    FDA Adverse Event Summary report: N

    1ST PICC S/L 26A (1.9F

    MDR report key: 4892640 · Received July 1, 2015

    Report

    Report Number
    1625425-2015-00017
    Date Received
    July 1, 2015
    Date of Event
    April 23, 2015
    Report Date
    June 26, 2015
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS ORIGINALLY RECEIVED VIA MEDWATCH NUMBER: (B)(4) AND NOT FROM THE CUSTOMER. THE CUSTOMER WAS CONTACTED REGARDING THE MEDWATCH REPORT. BASED ON THE INFO RECEIVED, THE PT DID NOT SUFFER SERIOUS INJURY OR DEATH. THE CATHETER CURLED UP IN THE BABY AND REQUIRED MEDICAL INTERVENTION TO ENSURE THE BROKEN CATHETER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVAL. A TRUE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECS AND DOCUMENTED PROCEDURES. CATHETERS ARE 100 INSPECTED AT VARIOUS STAGES DURING THE MFG PROCESS. A PRESSURE TEST IS PERFORMED ON ALL CATHETERS DURING MFG TO ENSURE THE CATHETERS CAN WITHSTAND THE PRESSURES AND FORCES WHEN UTILIZED WITHIN THE INSTRUCTIONS FOR USE. A CONTROL PULL TEST IS ALSO PERFORMED PER THE SPECS TO ENSURE CATHETER STRENGTH AND INTEGRITY. THE ARGON CLINICAL EVAL MANUAL PROVIDES DETAILS ON STEPS TO FOLLOW IF RESISTANCE TO REMOVAL IS ENCOUNTERED AND STATES THAT SOME CATHETERS MAY BE KNOTTED AND WILL NEED TO BE REMOVED THROUGH A VENOTOMY.

    Description of Event or Problem · 1

    RECEIVED PER MEDWATCH NUMBER: (B)(4). PICC COILED UPON ITSELF WHEN REMOVING WAS STUCK. THE PHYSICIAN USED SCALPEL AND FORCEPS TO REMOVE KNOTTED PICC. UPON VISUAL EXAM ALL OF PICC WAS REMOVED. AN X-RAY WAS OBTAINED TO CONFIRM THE PICC SEPARATED AT THE 15CM MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429523 1ST PICC S/L 26A (1.9F 1ST PICC FOZ 11078889

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA