BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 13986529 · Received April 1, 2022

    Report

    Report Number
    1820334-2022-00523
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    October 23, 2021
    Report Date
    September 27, 2022
    Manufacturer
    COOK INC
    Product Code
    GCB
    UDI-DI
    00827002094895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY REFERENCE NUMBER: (B)(4). 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: IT WAS REPORTED THAT A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. THE DEVICE WAS REQUIRED FOR A COMPUTED TOMOGRAPHY (CT) GUIDED DRAIN PLACEMENT INTO A PELVIC ABSCESS AND WAS PLACED VIA DIRECT STICK. AS THE PHYSICIAN WAS REMOVING THE DEVICE, THE HUB BROKE OFF. THE DEVICE WAS THEN REMOVED IN ITS ENTIRETY, AS THE ACCESS WIRE WAS STILL IN PLACE. THE PROCEDURE WAS COMPLETED "AS NORMAL" AND PATIENT OUTCOME WAS "AS EXPECTED." THE CUSTOMER NOTED THERE WAS NO DIFFICULT ADVANCEMENT OR FORCE EXERTED ON THE DEVICE. NO OBSTRUCTIONS WERE ENCOUNTERED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, AND A SUPPLIER INVESTIGATION WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. HOWEVER, 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 9488736 AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. ADDITIONALLY, A COMPLAINT DATA BASE SEARCH DID NOT FIND ANY ADDITIONAL COMPLAINTS FROM THE LOT. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THIS COMPLAINT DEVICE IS NOT CURRENTLY PACKAGED WITH INSTRUCTIONS FOR USE. THE AFFECTED COMPONENT IS SUPPLIED FROM MERIT MEDICAL SYSTEMS/MALVERN DIV. COOK REQUESTED THE SUPPLIER INVESTIGATE THIS MATTER. THE SUPPLIER REVIEWED THE DEVICE HISTORY RECORD FOR THIS DEVICE. THE SUPPLIER DID NOT FIND ANY DEVIATIONS OR NONCONFORMANCES ASSOCIATED WITH THIS LOT. THE SUPPLIER CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR THIS PRODUCT RELEASE WERE MET. A FAILURE MODE COULD NOT BE VERIFIED DUE TO NO DEVICE RETURN OR PHOTOS. IT WAS REPORTED THAT DURING THE PROCEDURE, THE HUB OF THE CATHETER BROKE OFF IN THE PATIENT. THE DEVICE WAS ABLE TO BE REMOVED AS AN ENTIRETY. THE PROCEDURE WAS COMPLETED AS NORMAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. BASED ON THE RETURNED SUPPLIER INVESTIGATION, COOK CONCLUDED THE CAUSE OF EVENT TO BE COMPONENT FAILURE. 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 A YUEH CENTESIS DISPOSABLE CATHETER NEEDLE SEPARATED. THE DEVICE WAS REQUIRED FOR A COMPUTED TOMOGRAPHY (CT) GUIDED DRAIN PLACEMENT INTO A PELVIC ABSCESS AND WAS PLACED VIA DIRECT STICK. AS THE PHYSICIAN WAS REMOVING THE DEVICE, AND THE HUB BROKE OFF. THE DEVICE WAS THEN REMOVED IN ITS ENTIRETY, AS THE ACCESS WIRE WAS STILL IN PLACE. THE PROCEDURE WAS COMPLETED "AS NORMAL" AND PATIENT OUTCOME WAS "AS EXPECTED". THE CUSTOMER NOTED THERE WAS NO DIFFICULT ADVANCEMENT OR FORCE EXERTED ON THE DEVICE. NO OBSTRUCTIONS WERE ENCOUNTERED. 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
    1013753 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK INC N/A 9488736 00827002094895

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male