BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE CATH

    MDR report key: 8281917 · Received January 28, 2019

    Report

    Report Number
    3005778470-2019-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 8, 2019
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K161344
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHYSICAL SAMPLE OR PICTURE OF DEFECTIVE PRODUCT HAS BEEN RECEIVED. THE PRODUCT WAS MANUFACTURED UNDER PRODUCT SPECIFICATION PROCESS INSTRUCTIONS. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER MATERIAL IDENTIFICATION 1718777, MANUFACTURING LOT # 8J00384 IN C2. THE PRODUCT WAS PACKED ON PACKAGING MACHINE P009 ACCORDING TO THE INSTRUCTION FOR PACKING. LOT # 8J00384 WAS STERILIZED UNDER STERILIZATION LOTS 24A180909,26 180912, 24A180910,24A180912, 25A180910,25A180912, 25A180911,26A180922, 26A180911. DURING IN- PROCESS INSPECTION PEEL TEST IS CARRIED OUT ACCORDING TO TESTING METHODS: PEEL-PACK MUST NOT BE WELDED SO HARD TO MAKE PAPER RESIDUE STAY ON THE FOIL OR CAUSE THE PAPER TEAR. A WELD MUST BE EVEN AND INTACT AFTER PEEL-PACK OPENING. THE WELD MUST BE WITHOUT FOLD, DOUBLE WELD OR OTHER IRREGULARITIES. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION PROCESS OF THE MENTIONED LOT. A QUERY WAS RUN FOR ON (B)(6) 2019 WHICH YIELDED ONE OCCURRENCE AGAINST ALL TYPE OF GLIDE CATHETERS WITH NEW PACKAGING DESIGN. THE NEW DESIGN INCLUDES THE FOLLOWING CHANGE: A LARGER HOLE AT THE TOP OF THE PACK ALLOWS FOR EASIER OPENING OF THE PACK AS WELL AS PROVIDING AN ADDITIONAL HANGING OPTION. THIS NEW PACKAGING DESIGN IS CALLED AS EASY USE PACK. NEW PACKAGING DESIGN FOR GLIDE CATHETERS WAS IMPLEMENTED IN JUNE 2018. A NON- CONFORMANCE HAS BEEN INITIATED. A ROOT CAUSE WAS DETERMINED AND THE CORRECTION HAD BEEN ALREADY PERFORMED: ROOT CAUSE ¿ INCORRECT OPENING OF THE PRIMARY PACKAGING BY END USER. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS INCORRECT OPENING OF PRIMARY PACKAGING BY END USER. POTENTIAL SOLUTION OF PACKAGE OPENING BY MODIFYING SEAL USED ON THE PACKAGING MACHINE WAS TESTED WITH POSITIVE RESULTS TO ENSURE THAT, END USER WILL OPEN PEEL PACK PROPERLY WITHOUT TEARING. ORIGINAL SEALS WERE ORDER FROM MULITIVAC. DRAWINGS OF PROPOSED MODIFICATION OF SEALS WERE SENT TO THE SUPPLIER, MODIFIED SEALS HAVE BEEN ORDERED TO THE SPARE PARTS WAREHOUSE AND TESTED. THIS SUPPLIER ORDER SEAL FROM MULTIVAC, THEN MODIFY SEAL AND DELIVER TO MICHALOVCE TO SPARE PARTS WAREHOUSE. NEW SEALS WERE AFTER TESTING AND CONFIRMATION OF POSITIVE RESULTS, IMPLEMENTED INTO PRODUCTION. THUS, NO FURTHER CORRECTIVE ACTION/PREVENTIVE ACTION ACTIVITIES ARE REQUIRED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE THE TERRITORY MANAGER WAS DEMONSTRATING THIS CATHETER FROM HIS STOCK AND PLACED A FINGER IN EACH FINGER HOLE OF THE PACKAGING IN ORDER TO OPEN THE CATHETER, THE PAPER SIDE OF THE PACKAGING TORE APART AND SPLIT OPEN CAUSING THE CATHETER TO FALL OUT. NO PHOTO OF THE AFFECTED PRODUCT WAS PROVIDED, HOWEVER PHOTO OF THE UNUSED PACKAGE TO SHOW THE FINGER HOLES WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75653 GENTLE CATH CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421910 8J00384

    Patients

    Seq Age Sex Outcome Treatment
    1