BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH OTHER

    MDR report key: 16397110 · Received February 17, 2023

    Report

    Report Number
    3005778470-2023-00087
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Report Date
    January 30, 2023
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    00768455145522
    PMA / PMN Number
    K172924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1706972, GENTLECATH IC TIEM CH12X405MM(1X100PK) US AND MANUFACTURING LOT #2E02498 ON C2, PACKAGING MACHINE P016 IN AMOUNT (B)(4) PCS IN JUNE 2022. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905703 PACKAGING PRODUCTS ON PACKAGING MACHINES. ACCORDING TO G905703, WITHIN IN-PROCESS CONTROL SEVERAL TESTS ARE CARRIED OUT: 5.9.3 VISUAL INSPECTION OF PAPER. NO VISUAL IMPURITIES ON PAPER ARE ALLOWED. 5.9.7 PERFORATION TEST ¿ ACCORDING TO RELEVANT TESTING METHOD TM-437. 5.9.10 PEEL TEST. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION PROCESS OF THE MENTIONED LOT. NO SAMPLE OR PICTURE WAS PROVIDED. THE BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. A QUERY WAS RUN AGAINST PRODUCT GENTLECATH IC FOR MALFUNCTION CODE UCA-PMC11.10 WHICH YIELDED 1 ANOTHER OCCURRENCE IN PAST 24 MONTHS. THIS ONE SIMILAR COMPLAINT HAS BEEN RECEIVED IN JULY 2021 AND IT WAS SIMILAR ISSUE AS IN THIS COMPLAINT, BUT PRODUCT WAS DIFFERENT - SAP MATERIAL ID 1706963, GENTLECATH IC NEL CH12X405MM(1X100PK) US. THE ISSUE OCCURRENCE IS CONSIDERED AS ISOLATED. NO FURTHER ACTION IS REQUIRED. ACCORDING TO DHF 737 HAR, PAGE 77 (HC09.02-S1), THE RISK EVALUATION WAS ASSESSED AS LOW.

    Additional Manufacturer Narrative · 0

    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: (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

    IT WAS REPORTED A CONSUMER OPENED QUANTITY 1 GC SAMPLE HE RECEIVED FROM HIS SUPPLIER TO TRIAL FOR THE FIRST TIME AND THE PACKAGING DID NOT TEAR EVENLY ALL THE WAY DOWN. CONSUMER STATED, AS HE "PULLED APART THE PLASTIC PART OF THE PACKAGING AND THE PAPER PART OF THE PACKAGING IT STARTED TEARING EVENLY AND CLEANLY IN 2 SEPARATE PIECES" BUT THEN HE CONTINUED TO PULL DOWN PAST THE FUNNEL HE SAID "THE PAPER PART OF THE PACKAGING STUCK TO THE SIDES WHERE THEY WERE GLUED DOWN" AND HE WAS ONLY LEFT WITH THE MIDDLE PORTION OF THE PAPER PACKAGING IN HIS HANDS AS HE TORE THAT ALL THE WAY DOWN TO THE BOTTOM. HE SAID HE "THEN APPLIES THE LUBRICANT TO THE CATHETER PRIOR TO USE" AND HIS CONCERN WAS RISK OF CONTAMINATION AS HE HAD THE TORN EDGES OF THE PAPER PACKAGING IN THE WAY. HE HAD THE CHALLENGE OF REMOVING IT WITHOUT CONTAMINATING IT BY BRUSHING UP AGAINST THE SIDES. HE SAID HE WAS "ABLE TO APPLY LUBRICANT AND REMOVE CATHETER AND STILL KEEP IT STERILE BY NOT TOUCHING THE SIDES AND USE THE PRODUCT BUT IT WAS A CHALLENGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263496 GENTLECATH OTHER CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 3208182 2E02498 00768455145522

    Patients

    Seq Age Sex Outcome Treatment
    1 Male