BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE PRODUCTS

    MDR report key: 16639953 · Received March 29, 2023

    Report

    Report Number
    1049092-2023-00036
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Report Date
    March 15, 2023
    Manufacturer
    CONVATEC INC
    Product Code
    KOD
    UDI-DI
    00815947020505
    PMA / PMN Number
    K080881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUPPLIER USED CAUSALITY ANALYSIS DURING INVESTIGATION. FINDING ARE AS BELOW: 1. PHOTOS OF UNQUALIFIED PRODUCTS ARE NOT PROVIDED, SO THEY COULD NOT KNOW THE EXACT SITUATION. THEY THINK THERE MAY BE SOME WRINKLES ON THE PAPER. AFTER SEALING WITH FILM, THE EDGE WRINKLE PART IS SLIGHT, THE WORKER DID NOT CHECK IT CAREFULLY, SO THE UNQUALIFIED ITEM WAS NOT PICKED OUT. THEN, THESE UNQUALIFIED ITEMS ARE SEND TO CUSTOMER. 2. FOR ¿¿CATHETERS STICK TO PACKAGE¿¿ ISSUE, THEY THINK THERE MAY BE SOME WORKERS HANDLED CATHETERS RIGHT AFTER DISINFECTED THEIR HANDS. THEIR HANDS ARE NOT DRY COMPLETELY, SO SOME PART ON CATHETERS ARE DAMP BECAUSE OF HANDS AND STICK TO PACKAGE. CONCLUSION: THIS IS HUMAN ERROR. THE SUPPLIER STATES THE FOLLOWING RETRAINING WILL BE PERFORMED: 1. WE WILL RE-TRAIN WORKERS WHO HANDLE THE HNC OUTER BOX PACKING AND MAKE SURE THEY UNDERSTAND THE CHECKING REQUIREMENTS; RE-TRAIN WORKERS OF THE HNC BLISTER PACKING LINE AND MAKE SURE THEY UNDERSTAND THE REQUIREMENT. 2. RE-TRAIN WORKERS OF HNC BLISTER PACKING LINE, HAND DRY IS REQUESTED AFTER HAND DISINFECTION, SO CATHETERS WILL NOT BE EFFECTED BY THE HAND DAMP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092, MANUFACTURING SITE: 3005471919.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CATHETER, UROLOGICAL. AGE: 81 YEARS. COMPLAINANT EMAIL: (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 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 "IT LOOKS LIKE THE WAY THE CATHETER WAS SEALED WAS MISALIGNED AND SEALED TOO CLOSE TO THE CATHETER ITSELF." END USER'S WIFE "THINKS IT IS THE HEAT FROM SEALING THAT CAUSED THE CATHETER TO STICK TO THE PACKAGING WHICH SHE SAID IS HALFWAY AT THE BEND IN THE CATHETER. CATHETER IS STICKING BEFORE AND AFTER BUSTING WATER SACHET. SHE ALSO SAID THE SEAL MISALIGNED IS CAUSING IT TO LEAK AT BOTTOM PRIOR TO OPENING PACKAGING AFTER BURSTING WATER SACHET BECAUSE IT WASN'T COMPLETELY SEALED AT BOTTOM/ TIP END. SHE SAID IT WILL LEAK OUT THE BOTTOM MAKING A MESS PRIOR TO OPENING PACKAGING. SHE SAID IT HAS BEEN "HIT OR MISS" IN THIS BOX, SOME WILL STICK AND LEAK OTHERS WILL JUST STICK AND NOT LEAK OR LEAK AND NOT STICK TO PACKAGING. SOME ARE OK TOO. THEY ARE TRYING TO REMOVE THEM FROM PACKAGING RIGHT AFTER BURSTING WATER SACHET AS WELL AFTER WATER HAS RAN ALONG ALL OF CATHETER. THEY HAVE BEEN USING THE ONES THAT THEY HAVE BEEN ABLE TO GET UNSTUCK. NO DIFFERENT FEEL IN URETHRA VS ONES THAT DO NOT HAVE DEFECT IF THEY CAN GET THEM UNSTUCK/ NO PAIN WITH USE. NO HARM REPORTED." HIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442241 CURE PRODUCTS CATHETER, UROLOGICAL KOD CONVATEC INC HM14UK 22610003 00815947020505

    Patients

    Seq Age Sex Outcome Treatment
    1 Male