BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 14959685 · Received July 8, 2022

    Report

    Report Number
    1820334-2022-01181
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    July 4, 2022
    Report Date
    November 10, 2022
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    10827002147796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME = LJE CATHETER, NEPHROSTOMY; FAD STENT, URETERAL. INITIAL REPORTER NAME AND ADDRESS: CUSTOMER ADDRESS = (B)(6). PMA/510KG4: PMA/510(K) NUMBER = 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 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT, AFTER OPENING THE PACKAGING OF A BANDER URETERAL DIVERSION STENT SET, IT WAS NOTED THAT THE HEAD END OF THE STENT WAS DISCONNECTED AND COULD NOT FUNCTION AS INTENDED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME CATALOG NUMBER. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), THE INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES. ONE BANDER URETERAL DIVERSION STENT WAS RETURNED IN AN OPEN PACKAGE. THE STENT WAS SEPARATED INTO TWO SECTIONS: SECTION 1 IS APPROX. 16.1 CM; SECTION 2 IS APPROX. 59.3CM. THE POINT OF SEPARATION IS SLIGHTLY JAGGED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, 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 THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. A DEFINITIVE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER OPENING THE PACKAGING OF A BANDER URETERAL DIVERSION STENT SET, IT WAS NOTED THAT THE HEAD END OF THE STENT WAS DISCONNECTED AND COULD NOT FUNCTION AS INTENDED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME RPN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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
    1986545 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL FAD COOK INC 14454525 10827002147796

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male