BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT KIT

    MDR report key: 17267381 · Received July 6, 2023

    Report

    Report Number
    9610711-2023-00130
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Report Date
    March 19, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K170362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE QUALITY DATABASE REVEALED A NON-CONFORMITY AND A CAPA IN RELATION WITH THE DESCRIBE DEFECT: CAPA-000030 "QUALITY IMPROVEMENT": THE DISTRIBUTION CENTER WAS TRAINED TO GOOD DISTRIBUTION PRACTICES IN JULY 2023, NC-003375 "KITTING ISSUES IN LPP": THE ACTIONS ARE ONGOING CONCERNING IMPROVEMENTS IN THE KITTING AREA. SIMILAR CASE STUDY WAS DONE BASED ON SAME ITEM NUMBER, SAME DEFECT (PACKAGING/LABELLING ERROR), OVER LAST FOUR YEAR, AND 6 OTHERS COMPLAINTS (SAME ISSUE BUT DUPLICATE FOR EMDR). A CLINICAL RISK ASSESSMENT WAS DONE. IN MOST OF THE CASES, THE SURGEON/THE NURSE WILL DETECT THE PROBLEM BEFORE THE SURGERY, AS GOOD PRACTICES REQUIRE TO PREPARE THE MATERIAL BEFORE THE SURGERY. NURSES AND SURGEONS SHOULD EASILY DETECT THE INCONSISTENCY BETWEEN LABELLING AND PRODUCT. AT TIME, THERE WERE NO CLINICAL CONSEQUENCES SINCE THE INCONSISTENCY BETWEEN LABELLING AND PRODUCT WAS DETECTED BEFORE SURGERY. SEVERAL POTENTIAL CLINICAL RISKS ASSOCIATED WITH THIS INCIDENT HAVE BEEN IDENTIFIED. THEY ARE ASSOCIATED WITH: MINOR INCONVENIENCE FOR THE OPERATOR OR MINOR PROLONGED PROCEDURE.THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A NEW EVALUATION OF THE SEVERITY OR AN UPDATE OF THIS DOCUMENT MAY BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART. BASED ON THIS, WE CAN CONCLUDE THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION A PACKAGING ERROR WAS OBSERVED, A STENT CH8 WAS PACKAGED INSTEAD OF STENT CH7 DURING KIT STEP. AN INVESTIGATION WAS ASKED TO THE WAREHOUSE CONCERNED. THEY WAS INFORMED ABOUT THIS DEFECT FOR THIS PRODUCT. IT¿S AN OPERATOR ERROR SO AN AWARENESS HAS BEEN DONE WITH THE TWO OPERATORS CONCERNED ABOUT THIS TOPIC IN AUGUST.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE ITEM NUMBER SHOULD CONTAIN A 7CH/26CM DEVICE; HOWEVER, PACKAGED WAS AN 8CH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990118 VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENT KIT UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE FAD COLOPLAST A/S 9070782_BCFG743002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown