BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 10747869 · Received October 28, 2020

    Report

    Report Number
    1820334-2020-01950
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Report Date
    March 19, 2021
    Manufacturer
    COOK INC
    Product Code
    GCB
    UDI-DI
    00827002101005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    . ADDITIONAL INFORMATION: D9- PRODUCT RECEIVED ON: 22DEC2020 INVESTIGATION - EVALUATION (B)(6) FROM DARTMOUTH-HITCHCOOK MEDICAL CENTER IN THE UNITED STATES INFORMED COOK ON 15OCT2020 OF AN INCIDENT INVOLVING A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE [RPN: DTVN-5.0-19-15.0-YUEH-RDC-070896] FROM LOT NUMBER 13351768. DURING PREPARATION FOR A PROCEDURE, THE HUB OF THE CATHETER SEPARATED. AN ADDITIONAL PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WAS CONDUCTED DURING THE INVESTIGATION. ONE PRIOR TO USE DEVICE AND ONE UNUSED DEVICE WERE RETURNED TO COOK FOR INVESTIGATION. A VISUAL INSPECTION OF THE PRIOR TO USE DEVICE FOUND THE HUB TO BE SEPARATED FROM THE CATHETER. NO DAMAGE TO THE FLARE WAS NOTED. DIMENSIONAL VERIFICATION OF THE INNER DIAMETER OF THE CAP CONFIRMED MEASUREMENTS TO BE WITHIN MANUFACTURING TOLERANCE. UPON OPENING, A VISUAL INSPECTION OF THE UNUSED DEVICE FOUND THE HUB TO BE APPROPRIATELY CONNECTED TO THE CATHETER. PULLING ON THE HUB DID NOT RESULT IN SEPARATION. COOK HAS CONCLUDED THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. 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 DESIGN HISTORY FILE (DHF) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT (13351768) REVEALED ONE RELEVANT RECORDED NON-CONFORMANCE FOR "FLARE, INADEQUATE" IN WHICH ONE DEVICE WAS SCRAPPED. THERE IS A 100% CHECK FOR THIS NON-CONFORMANCE PRIOR TO RELEASE. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO ADDITIONAL COMPLAINTS FROM THE SAME LOT, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING THAT NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. THE COMPLAINT DEVICE IS NOT SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU), SO A REVIEW OF THE PRODUCT LABELING COULD NOT BE COMPLETED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE HAS BEEN TRACED TO COMPONENT FAILURE UNRELATED TO A DEFICIENCY IN MANUFACTURING/DEVICE DESIGN. IT IS POSSIBLE THE PATIENT PULLED ON THE DEVICE, CAUSING THE HUB TO SEPARATE. HOWEVER, THIS CANNOT BE CONFIRMED AT THIS TIME. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

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

    Additional Manufacturer Narrative · 1

    RPN: DTVN-5.0-19-15.0-YUEH-RDC-070896. OCCUPATION: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT REQUIRED A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE FOR AN UNKNOWN PROCEDURE. DURING PREPARATION, THE HUB SEPARATED FROM THE CATHETER. THE DEVICE DID NOT MAKE PATIENT CONTACT. NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211484 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK INC N/A 13351768 00827002101005

    Patients

    Seq Age Sex Outcome Treatment
    1