BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 16622563 · Received March 27, 2023

    Report

    Report Number
    1820334-2023-00325
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 7, 2023
    Report Date
    August 16, 2023
    Manufacturer
    COOK INC
    Product Code
    GCB
    UDI-DI
    00827002101005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: (B)(6) (UNITED STATES) INFORMED COOK ON 07MAR2023 OF AN ISSUE WITH A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE (RPN: DTVN-5.0-19-15.0-YUEH-RDC-070896, LOT: 15136910). THE CUSTOMER STATED THE CANNULA WOULDN¿T LOAD INTO THE PIGTAIL DRAINAGE CATHETER. THE DEVICE DID NOT MAKE PATIENT CONTACT. NO ADVERSE EFFECTS HAVE BEEN REPORTED. UPON INITIAL INVESTIGATION OF THE RETURNED DEVICE, IT WAS DISCOVERED THAT THE CATHETER IS SEPARATED NEAR THE FLARE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. A TOTAL OF FOUR PRIOR TO USE DEVICES WERE RECEIVED FOR EVALUATION, IN WHICH THREE OF THE PRODUCTS WERE FOUND TO FUNCTION WITHOUT ISSUES. THE METAL CANNULAS WERE ABLE TO BE ADVANCED THROUGH THE CATHETERS WITHOUT DIFFICULTY. THE FOURTH DEVICE WAS NOTED TO HAVE SHAFT DAMAGE NEAR THE FLARE, AND THE FLARE WAS FOUND TO BE PULLED OUT FROM THE HUB. THE METAL CANNULA WAS LODGED INSIDE OF THE CATHETER. DIMENSIONAL ANALYSIS CONFIRMED THAT THE CATHETER AND CANNULA WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS. 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 DEVICE HISTORY RECORD (DHR) FOR LOT 15136910 FOUND TWO POSSIBLY RELATED NONCONFORMANCES, IN WHICH ALL AFFECTED DEVICES WERE SCRAPPED, AND THE REMAINING WERE 100% INSPECTED PRIOR TO FURTHER PRODUCTION. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK WAS UNABLE TO REVIEW PRODUCT LABELING, AS THIS DEVICE IS CURRENTLY NOT PACKAGED WITH AN INSTRUCTIONS FOR USE (IFU). EVIDENCE GATHERED FROM A REVIEW OF THE DMR, DHR, AND DEVICE FAILURE ANALYSIS, SUGGESTS THAT THERE IS NO INDICATION THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. THE CUSTOMER STATED THE CANNULA WOULDN¿T LOAD INTO THE PIGTAIL CATHETER. UPON DEVICE RETURN, ONE OF THE CATHETERS APPEARED TO HAVE SHAFT DAMAGE AND THE FLARE WAS PULLED FREE FROM THE HUB. THE CANNULA WAS STILL LODGED INSIDE THE CATHETER. IT¿S POSSIBLE THAT WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE CANNULA, EXCESSIVE FORCE WAS USED, RESULTING IN THE CATHETER DAMAGE, HOWEVER THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 OR UNAVAILABLE. RPN: DTVN-5.0-19-15.0-YUEH-RDC-070896. 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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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 PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF YUEH CENTESIS DISPOSABLE CATHETER NEEDLE WAS DIFFICULT TO ADVANCE INTO THE DEVICE CATHETER. THE DEVICE WAS REQUIRED FOR A PARACENTESIS. WHEN PREPPING THE DEVICE, THE NEEDLE WOULD NOT ADVANCE INTO THE PIGTAIL CATHETER. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT. AN ADDITIONAL LIKE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON INITIAL INVESTIGATION OF THE RETURNED DEVICE, IT WAS DISCOVERED THAT THE CATHETER IS SEPARATED NEAR THE FLARE, THUS PROMPTING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808730 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK INC N/A 15136910 00827002101005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown