BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 19725260 · Received July 11, 2024

    Report

    Report Number
    1820334-2024-00941
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 28, 2024
    Report Date
    November 20, 2024
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002575820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 -CATALOG NUMBER: DEVICE IS NOT MARKETED IN THE UNITED STATES. THERE ARE SIMILAR DEVICES MARKETED IN THE UNITED STATES, FOR EXAMPLE CATALOG NUMBER 025707-S1. INFORMATION FOR 025707-S1: D2A - COMMON DEVICE NAME: FAD STENT, URETERAL, D2B -PRO CODE: FAD. G4 PMA/510(K) #: K181971. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTIONS: D4: MODEL # = GPN # INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THE BANDER URETERAL DIVERSION STENT SET'S PACKAGE CONTAINED FOREIGN MATTER PRIOR TO A STENT EXCHANGE FOR URETERAL CUTANEOUS ULCER PROCEDURE. THE FOREIGN MATTER WAS FOUND PRIOR TO OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE STOCKED IN THE HOSPITAL. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL (QC) PROCEDURES, AND INSPECTION OF UNUSED PRODUCT WERE CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION THE DEVICE WAS RETURNED UNOPENED. FOREIGN MATTER COULD BE SEEN INSIDE THE STERILE BARRIER. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND ONE RELATED NON-CONFORMANCE REPORTED FOR LOT. THE NONCONFORMANCE WAS POSSIBLY RELATED TO THE CUSTOMER COMPLAINT BUT THE NONCONFORMANCE WAS SCRAPPED. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. WHILE THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS, THE RELATED NONCONFORMANCES WERE SCRAPPED, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING; THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: ¿HOW SUPPLIED ¿ DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE.¿ BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT WAS A QUALITY CONTROL DEFICIENCY; EMPLOYEE AWARENESS OF THE ISSUE WAS CONDUCTED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BANDER URETERAL DIVERSION STENT SET'S PACKAGE CONTAINED FOREIGN MATTER PRIOR TO A STENT EXCHANGE FOR URETERAL CUTANEOUS ULCER PROCEDURE. THE FOREIGN MATTER WAS FOUND PRIOR TO OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE STOCKED IN THE HOSPITAL. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426503 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL FAD COOK INC G57582 15168871 00827002575820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown