BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 15589719 · Received October 12, 2022

    Report

    Report Number
    1820334-2022-01629
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 23, 2022
    Report Date
    February 24, 2023
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002481763
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: X-RAY TECHNICIAN. PMA/510(K) #: K171603. ADDITIONAL CUSTOMER INFORMATION - POSTAL CODE: (B)(6), MOBILE: (B)(6). 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

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED ON 03OCT2022 BY A REPRESENTATIVE OF CHANGI GENERAL HOSPITAL (SINGAPORE) THAT AN ULTRATHANE COPE NEPHROURETEROSTOMY SET (RPN: ULT8.5-8.5-24-NUCL-B-RH; LOT#: NS14701338) LEAKED AT THE HUB. AFTER THE DEVICE WAS PLACED IN THE PATIENT, LEAKAGE FROM THE HUB WAS NOTED. AS A RESULT, THE COMPLAINT DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. IT IS UNKNOWN HOW LONG THE DEVICE WAS IN PLACE PRIOR TO FAILURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RECEIVED IN A USED CONDITION, WITH THE HUB AND A SMALL SECTION OF THE TUBING CUT AWAY FROM THE MAIN SHAFT. THE INVESTIGATION CONFIRMED THERE WAS ONE THREAD SHOWING BETWEEN THE CAP / MAC-LOC ADAPTER CONNECTION SITE, PASSING THE REQUIRED GAP GAUGE REQUIREMENT. DURING TABLE TOP TESTING, A LEAK TEST CONFIRMED FLUID ESCAPING AT THE CAP / MAC-LOC ADAPTOR CONNECTION SITE. A VISUAL EXAMINATION DISCOVERED A SECTION OF THE FLARE BUNCHED/FOLDED INSIDE THE LUMEN OF THE MAC-LOC ADAPTOR. THE CAP AND MAC-LOC ADAPTOR WERE DISASSEMBLED, DISCOVERING THE PRESENCE OF THREAD MARKS, A CREASE AND A TEAR IN THE FLARE. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE CURRENTLY IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THIS DEVICE IS 100% INSPECTED FOR THIS FAILURE IN PROCESS. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT NS14701338 AND SUBASSEMBLY LOTS MAC-LOC SA14606405 / SA14625983 CONFIRMED THERE WERE NO RELEVANT RECORDED NONCONFORMANCES. A FURTHER SEARCH OF THE REPORTED LOT NUMBER DISCOVERED NO OTHER COMPLAINTS BEING RECEIVED. COOK DID NOT FIND EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK REVIEWED THE PRODUCT LABELING FOR THE COMPLAINT DEVICE. THE INSTRUCTIONS FOR USE (IFU) [T_NUCL_REV5, COPE NEPHROURETEROSTOMY STENTS] PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "PRECAUTIONS PATIENTS WITH INDWELLING DRAINAGE CATHETERS SHOULD BE EVALUATED ROUTINELY TO ENSURE CONTINUOUS FUNCTION OF THE CATHETER. HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. " BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO A MANUFACTURING DEFICIENCY. THE FLARE WAS MANUFACTURED OUT OF SPECIFICATION. THE APPROPRIATE RESPONSIBLE MANUFACTURING DEPARTMENT WAS ISSUED A DEFECT AWARENESS TRAINING. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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 THAT THE CATHETER HUB IN AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS LEAKING AFTER INSERTION. IT IS UNKNOWN AT THIS TIME HOW LONG THE DEVICE WAS IN PLACE. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE CATHETER AND REPLACE WITH A NEW DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    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
    2920248 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A NS14701338 00827002481763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention