BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMG CATHETER KIT 14 FR

    MDR report key: 6380441 · Received March 6, 2017

    Report

    Report Number
    3004365956-2017-00069
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 5, 2017
    Report Date
    February 8, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) PICTURE OF THE DEVICE WAS RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION A CATHETER CAN BE OBSERVED WITH SIGNS OF BLOOD AROUND IT. NO OTHER ISSUES WERE FOUND. CURRENT STOCK OF FG RLA-142-3 (MMG CATHETER KIT 14 FR) BATCH NUMBER 74B1701121 WAS INSPECTED. DURING THE INSPECTION NO ISSUES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO FUNCTIONAL INSPECTION CAN BE PERFORMED SINCE THE DEFECTIVE SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, SAMPLES OF CURRENT STOCK OF SUBASSEMBLY MMG14FM LOT NO. 2182272 WHICH WERE AVAILABLE AT THE ASSEMBLY LINE WERE INSPECTED WITH NO ISSUES FOUND. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CONCLUSION CAN BE ESTABLISHED AT THIS TIME BASED ON THE LACK OF DEFECTIVE OF SAMPLE. IT IS NECESSARY THE PHYSICAL SAMPLE IN ORDER TO PERFORM A PROPERLY INVESTIGATION. IF THE PRODUCT SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE REOPENED. OTHER REMARKS: THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE LACK OF A PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. ALTHOUGH THE CONDITION REPORTED IS OBSERVED ON THE PICTURE PROVIDED, THERE IS NO SUFFICIENT EVIDENCE TO ASSURE THAT THIS ISSUE WAS ORIGINATED DURING THE MANUFACTURING ASSEMBLY. THE ROOT CAUSE FOR THE CONDITION REPORTED COULD NOT BE IDENTIFIED WITHOUT THE PHYSICAL SAMPLE. HOWEVER, THE PERSONNEL FROM THE ASSEMBLY LINE HAVE BEEN NOTIFIED FOR AWARENESS. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ONCE THE CATHETER WAS INSIDE AT ABOUT 80% IT FOLDS AND GOES IN FOLDED AS NO URINE COMES OUT EVEN THOUGH IT IS FULLY INSERTED, ONCE PULLED OUT IT CAUSES A CUT AND BLEEDING. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162443 MMG CATHETER KIT 14 FR KOD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1