BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH AIR

    MDR report key: 16801367 · Received April 24, 2023

    Report

    Report Number
    3005778470-2023-00105
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Report Date
    April 19, 2023
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    UDI-DI
    00768455196272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS, PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY OF THIS NATURE HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE MENTIONED LOT. THE BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. BASED ON THE COMPLAINT ISSUE REPORTED THE CATHETER WAS WELDED WITH THE SPOT WELD. THIS ISSUE WAS OBSERVED SEVERAL TIMES IN PRODUCTION AREA TOO, THEREFORE THE ISSUE WAS SUBMITTED TO R&D DEPARTMENT AS THE PRODUCT IN QUESTION IS NEW PRODUCT. TO AVOID WELDING THE SLEEVE WITH SPOT WELD R&D SET UP THE SPOT WELD ON NOMINAL ON MARCH 23, 2022. THE SET UP WAS RECORDED IN LOGBOOK. THE LOT IN QUESTION WAS PRODUCED BEFORE THE SET UP IN QUESTION. WE HAVE RECEIVED ONE ANOTHER COMPLAINT WITH MALFUNCTION CODE UCA-PMC11.07 PRIMARY PACK HAS INCOMPLETE OR OPEN SEAL / WELD, OR IS TORN, RIPPED DAMAGED, SPLIT, CRACKED OR CRUSHED OR CONTAINS HOLES OR EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS), OR DRESSING OR LOOSE MATERIAL IS TRAPPED IN PACKAGING SINCE THE BEGINNING OF GCAFM PRODUCTION ¿ (B)(4) (GC CATH PROTECTIVE SHEATH WAS WELDED). NO HARM WAS REPORTED WITH THIS COMPLAINT. BASED ON ABOVE THE COMPLAINT ISSUE IS CONSIDERED AS VERY ISOLATED. 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

    PATIENT AGE: AGE: 87. COMMON DEVICE NAME: CATHETER, URETHRAL. PROCODE: GBM. 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 REPORTING SITE: 1049092. MANUFACTURING SITE: 3005778470.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED "WHILE TRYING TO TAKE THE CATHETER OUT, THE CATHETER TORE A HOLE IN THE BOTTOM OF THE PACKAGE. CATHETER WAS SEALED TO THE BOTTOM OF THE CATHETER PACKAGE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492427 GENTLECATH AIR CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 510690 2H03554 00768455196272

    Patients

    Seq Age Sex Outcome Treatment
    1 Male