BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 10936549 · Received December 2, 2020

    Report

    Report Number
    3005778470-2020-00213
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Report Date
    November 17, 2020
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MDR (B)(4) / FOLLOW-UP REPORT (B)(4) D.4: INSERTED UDI NUMBER (B)(4), FOR COMPLETENESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 3005778470.

    Additional Manufacturer Narrative · 0

    THE PHOTO OF AFFECTED PRODUCT WAS RECEIVED AND INSPECTED. THE SAMPLE DID NOT MEET SPECIFICATION. THE CATHETER WAS WELDED INTO THE WELD OF THE POUCH PACKAGE. THE PRODUCT WAS MANUFACTURED UNDER PRODUCT SPECIFICATION PR60-107 VER 5.0. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER MANUFACTURING LOT # 9C04522 IN C2. THE CATHETERS WERE PACKED IN PEELPACKS (POUCH) UNDER LOT IN APRIL 2019 ON PACKAGING MACHINE P009. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905704. LOT 9C04522 WAS STERILIZED UNDER STERILIZATION LOT 25A190410, 26A190410, 25A190412, 24A190412/24 190506. DURING PACKAGING IN- PROCESS INSPECTION THE TEST WITH FOCUS ON CATHETERS SQUEEZED IN WELDING WAS CARRIED OUT ACCORDING TO TM-437 VISUAL INSPECTION OF WELDING CATHETERS IN PEELPACK : PROCEDURE 3.1 HOLD SAMPLE AT GOOD VISUAL DISTANCE, 3.2 ENSURE ADEQUATE LIGHTING IN INSPECTION AREA. 3.3 LOOK AT ENTIRE PEELPACK SHEET IF THERE IS NO WELDING CATHETERS. 3.4 NO WELDING CATHETERS ARE ALLOWED. THE ENTIRE PEELPACK SHEET IS HELD UP TO CHECK THAT ALL CATHETERS ¿DROP DOWN¿ IN THE PACK. 3.5 WELDING CATHETERS INSIDE PEELPACK HAVE TO BE DISCARDED. RESULT OF THE INSPECTION IS RECORDED IN FORM G905704. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED. NO NONCONFORMITY RELATED TO THE ISSUE REPORTED HAD BEEN REGISTERED DURING THE PACKAGING PROCESS OF THE MENTIONED LOT. PHOTO WAS RECEIVED TO THE COMPLAINT AND REPORTED ISSUE WAS CONFIRMED. SEVERAL COMPLAINTS OF THIS NATURE WERE RECEIVED IN THE PAST AND THE ISSUE WAS INVESTIGATED WITHIN NC EVENT TW # 1181258. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT TW # 1181258 HAS BEEN APPROVED AND IS COMPLETE. FIVE MOST PROBABLE ROOT CAUSES WERE IDENTIFIED DURING THE INVESTIGATION AND ADDRESSED WITHIN CAPA 1216197. RC1: CAVITY IS NOT SPACIOUS ENOUGH TO COMPENSATE SMALL DEVIATIONS IN SHAPE. RC2: NOT DEFINED STORING OF THE CATHETERS IN BOXES ¿ THERE IS DEFINITION IN PROCEDURE FOR CORRECT CATHETERS STORING IN BOXES ACTUALLY. IN PRODUCTION DATE OF COMPLAINED CATHETERS THERE WAS EFFECTIVE PROCEDURE, WITH NO EXACTLY DEFINITION OF CATHETERS STORING. CC1: EXTRUSION PRODUCTION PROCESS AND BOBBIN CONSTRUCTION. - IT IS STANDARD PROCESS, SO IT WILL BE EXCLUDED FROM CAPA PLAN. CC2: NEGLECT OF THE OPERATOR. RC3: NOT PROPER METHOD DEFINED IN THE PROCEDURE RC4: ANY MACHINE DETECTION FOR CATHETER PLACEMENT. RC5: ANY MACHINE DETECTION FOR CATHETER SQUEEZING IN WELD. THIS ROOT CAUSES WERE ADDRESSED WITHIN CAPA 1216197. THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: 1:DEFINITION OF CORRECT WATER SACHET PLACEMENT TO THE CAVITY IN WORK INSTRUCTION G905704. 2: ORDER OF GUIDES FOR PACKING MACHINE P009 AND INSTALLATION THEM. 3. UPDATE OF WORK INSTRUCTIONS G905704, G905718. THE GUIDES WERE INSTALLED IN PACKAGING MACHINE P009 ON MARCH 6TH 2020. THE LOT IN QUESTION WAS PRODUCED BEFORE ALL CORRECTIVE ACTIONS IMPLEMENTATION. NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4), MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 1. (B)(6). 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. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PRODUCT DISTRIBUTOR THAT A PATIENT RECEIVED THE CATHETER "GET FLATTENED". UPON FURTHER INVESTIGATION IT WAS REPORTED THAT THE CATHETER WAS CAUGHT IN THE WELDING OF THE PACKAGING. A PHOTO WAS RECEIVED DEPICTING THE REPORTED COMPLAINT ISSUE. THE PRODUCT WAS NOT USED, NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399621 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421565 9C04522

    Patients

    Seq Age Sex Outcome Treatment
    1