BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO URO/ISC

    MDR report key: 15519283 · Received September 30, 2022

    Report

    Report Number
    3005778470-2022-00084
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Report Date
    September 23, 2022
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME:UNOMEDICAL NELATON CATHETER. 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: (B)(4). MANUFACTURING SITE: (B)(4).

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1266041 AND MANUFACTURING LOT #1E00216 IN C2 IN MAY 2021 IN AMOUNT 45 000 PCS ON PACKAGING MACHINE P010. PACKAGING OF PRODUCTS WAS RUN ACCORDING TO G905703 VER. 68.0 THE CATHETERS WERE ASSEMBLED UNDER SUBASSEMBLY LOT # 1E00206 IN MAY 2021 ON MACHINE A095. DURING PRODUCTION OF THIS LOT, CATHETERS WERE INSPECTED ACCORDING TO G905500 V.44.0 AND RESULTS WERE RECORDED INTO THE G905500 V. 44.0 ATTACHMENT 2: - SECTION 5.11 SUBSECTION 4: FOREIGN BODIES IN/ON TUBE ARE NOT ALLOWED. - 100% INSPECTION IS CARRIED OUT AS PART OF IN PROCESS CONTROL. DURING PRODUCTION OF CATHETERS WAS USE TUBE 1337683 LOTS 1D04409, 1D04410, 1E00845. TUBES WERE MANUFACTURED IN MAY 2021 ON MACHINE E034 ACCORDING TO PROCESS INSTRUCTION G905450 VER. 35.0. 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. THE PROCESS PARAMETERS WERE ADJUSTED WITHIN THE VALIDATED WINDOW. THE CORRECT RAW MATERIALS WERE USED DURING LOT PRODUCTION. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION PROCESS OF THE MENTIONED LOTS. NO OTHER COMPLAINT WAS RECEIVED ON THE LOT AND MALFUNCTION CODE UCA-PMC09.02 FOREIGN MATTER WITHIN PRODUCT. FIVE OTHER SIMILAR COMPLAINTS WERE RECEIVED ON THE SAME ISSUE WITH DIRTY ON CATHETER: (B)(4). ALL THESE COMPLAINTS WERE RECEIVED FROM THE SAME CUSTOMER. A PHOTO AND 11 SAMPLES HAVE BEEN RECEIVED TO THE COMPLAINTS , WHICH WERE EVALUATED IN ACCORDANCE WITH WI-0359. IMPURITIES ARE VISIBLE ON THE RECEIVED SAMPLES, WHICH CANNOT BE REMOVED FROM THE TUBE. CUSTOMER CANNOT SPECIFY FROM WHICH OUR LOT THE SAMPLES CAME FROM. THE EXACT NUMBER OF DEFECTIVE CATHETERS COULD NOT HAVE BEEN SPECIFIED TOO. THIS ISSUE WAS INVESTIGATED DEEPLY WITH EVENT (B)(4) (CH-22268). RCI HAS BEEN CLOSED WITH FOLLOWING CONCLUSION: ¿INVESTIGATION TEAM CONCLUDE THAT SOURCE OF DIRT ON CATHETER DID NOT CAUSE IN PRODUCTION PROCESS IN CONVATEC MICHALOVCE. THERE IS A HIGH PROBABILITY THAT SOURCE OF DIRT IS FROM TOUCH OF CATHETER AND PRINTED FOIL DURING STERILIZATION OF CUSTOM PROCEDURAL TRAY. ALSO, DIRT IS PLACED ON THE CATHETER RIGHT IN THE AREA OF TOUCH WITH PICTOGRAM THAT IS PLACED ON CUSTOMER POUCH AND IT IS ALWAYS ACROSS THIS AREA. THIS ASSUMPTION SUPPORT ALSO THAT UNO FEMALE CATHETER IS HIGH-RUNNER PRODUCT WHICH IS SHIPPED TO SEVERAL OTHER CUSTOMERS. AT LEAST 2 YEARS WE DIDN¿T RECEIVE ANY COMPLAINTS FROM OTHER CUSTOMERS WHERE THIS PRODUCT HAVE BEEN SHIPPED TO. IN OUR PRODUCTION IS 100% VISUAL CHECK AFTER ASSEMBLY ON CATHETER AUTOMATE AND NEVER HAVE SEEN THIS KIND OF NONCONFORMITY ON PRODUCT.¿ 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

    IT WAS REPORTED "DIRT ON CATHETER". PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337101 UNO URO/ISC CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. ZT02017182 1E00216

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown