BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 14733090 · Received June 17, 2022

    Report

    Report Number
    1820334-2022-01017
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    October 26, 2021
    Report Date
    October 3, 2022
    Manufacturer
    COOK INC
    Product Code
    GCB
    UDI-DI
    00827002094895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION: IR LEAD TECH. PMA/510(K) #: EXEMPT. 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. (B)(6) MEDICAL CENTER (UNITED STATES) INFORMED COOK ON 27OCT2021 OF AN INCIDENT INVOLVING A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE. IT WAS REPORTED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. DURING AN IMAGE-GUIDED PARACENTESIS, THE DEVICE WAS PLACED IN THE PATIENT AND IMMEDIATELY BEGAN LEAKING. THEN THE HUB DISCONNECTED AND THE CATHETER NEEDLE WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. A NEW DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. A REVIEW OF THE COMPLAINT HISTORY AND DEVICE HISTORY RECORD (DHR) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DHR FOR LOT 14083164 REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. IT IS POSSIBLE THAT DEVICE WAS DAMAGED DURING SHIPMENT/ STORAGE, HOWEVER THIS CANNOT BE DEFINITIVELY CONFIRMED. 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 A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. DURING AN IMAGE-GUIDED PARACENTESIS, THE DEVICE WAS PLACED IN THE PATIENT AND IMMEDIATELY BEGAN LEAKING. THEN THE HUB DISCONNECTED AND THE CATHETER NEEDLE WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT. A NEW DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES 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
    1311055 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK INC N/A 14083164 00827002094895

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male