BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMALE CATHETR 5-3/4 14FR

    MDR report key: 6477488 · Received April 10, 2017

    Report

    Report Number
    2523190-2017-00046
    Event Type
    Injury
    Date Received
    April 10, 2017
    Report Date
    March 27, 2017
    Manufacturer
    INTEGRA - MILTEX
    Product Code
    FBX
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 04/10/2017 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - PICTURES PROVIDED BY THE CUSTOMER, STATING THAT THE CATHETERS ARE SHARP AND ARE STRIPPING OFF FLESH. UPON FURTHER INVESTIGATION, A 1.5AQL WAS PERFORMED ON EXISTING INVENTORY; IT IS FOUND THAT NONE OF THE CATHETERS HAVE SHARP EDGES. ACCORDING TO THE ATTACHED PICTURES PROVIDED BY THE END USER, WE ARE UNABLE TO DETECT PRODUCT MARKINGS AND PRODUCT ID; THEREFORE THE COMPLAINT IS UNCONFIRMED. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THERE WERE PICTURES OF THE NON-CONFORMING CATHETERS PROVIDED BY THE END USER AND THE COMPLAINT REPORT STATING THAT THEY ARE STRIPPING OFF FLESH. ACCORDING TO THE ATTACHED PICTURES PROVIDED BY THE END USER, WE ARE UNABLE TO DETECT PRODUCT MARKINGS AND PRODUCT ID; THEREFORE THE COMPLAINT IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    ON 5/31/2017 INTEGRA INVESTIGATION COMPLETED. DEVICE HISTORY EVALUATION - THERE WERE NINE FEMALE CATHETER RETURNED 4 OUT OF THE NINE WAS DAMAGED/SHARPED. THE COMPLAINT REPORT HAS BEEN CONFIRMED; THE ROOT CAUSE HAS BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY. APPROPRIATE ACTION HAS BEEN IMPLEMENTED TO RECTIFY THIS MANUFACTURING DEFICIENCY.

    Description of Event or Problem · 1

    DEALER INITIALLY REPORTS STRIPPING OF FLESH. ON 4/3/2017 PATIENT REPORTS "THE NEW (URETHRAL) CATHETERS WERE MANUFACTURED DIFFERENTLY & HAVE SHARP EDGES WHICH HAS TAKEN SMALL PIECES OF FLESH AFTER MY BLADDER HAS BEEN EMPTY UPON REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260018 FEMALE CATHETR 5-3/4 14FR M18 - UROLOGY FBX INTEGRA - MILTEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other