BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    MDR report key: 7481007 · Received May 2, 2018

    Report

    Report Number
    1820334-2018-01307
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    February 24, 2018
    Report Date
    June 5, 2018
    Manufacturer
    COOK INC
    Product Code
    KOB
    UDI-DI
    00827002558014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER CORRECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K140085. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE INVESTIGATION INCLUDED A VISUAL INSPECTION OF THE RETURNED PRODUCTS. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND THE DEVICE SPECIFICATIONS. FOUR UNOPENED PACKAGES LABELED RPN ULCS-8-30 AND LABEL LOT 6257558X WERE RECEIVED FOR INVESTIGATION. ALL OF THE RETURNED PACKAGES WERE OPENED DURING THIS INVESTIGATION. THREE OF THE PACKAGES CONTAINED ALL OF THE SET COMPONENTS EXCEPT FOR THE UNV-090020-ET NEEDLE. THE FOURTH SET IS MISSING THE UNV-090020-ET NEEDLE AND UNV-DIL-060020 DILATOR. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THERE WERE NO NON-CONFORMANCES NOTED FOR THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY REVEALED TWO (2) ADDITIONAL COMPLAINTS FOR THE SAME ISSUE FOR LOT NUMBER 6257558X. ALL COMPLAINTS FOR THIS ISSUE WERE RECEIVED FROM THIS SAME FACILITY. AS FOUND IN THE INSTRUCTIONS FOR USE (IFU): SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE EVIDENCE PRESENTED BY THE RETURNED SAMPLES, THIS EVENT HAS BEEN ATTRIBUTED TO A MANUFACTURING EVENT. ADDITIONAL MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON OPENED THE UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER SET, THE NEEDLE WAS MISSING AND THEY DIDN'T HAVE ANOTHER NEEDLE IN STOCK AS THE OTHER SETS THEY HAD WITH THE SAME LOT NUMBER WERE ALSO MISSING THEIR NEEDLES. THE PUNCTURE PART OF THE PROCEDURE COULD NOT BE CARRIED OUT AS A RESULT. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THEY HAD TO CANCEL THE CASE AND TO RESCHEDULE THE PATIENT LATER WHEN THEY COULD GET EQUIPMENT FROM ANOTHER HOSPITAL. THE KIT DOES NOT CONTAIN A PUNCTURE NEEDLE YET THE LISTING OF CONTENTS INDICATES A 18 G X 20 CM NEEDLE. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE NEEDLE LISTED IN THE BILL OF MATERIALS WAS MISSING FROM THE SET. THIS ACCOUNT HAD A TOTAL OF SEVEN DEVICES FROM THE SAME LOT NUMBER THAT WERE MISSING THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322143 UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) KOB COOK INC 00827002558014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention