BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVER ACCESS AND BIOPSY SET

    MDR report key: 16375059 · Received February 14, 2023

    Report

    Report Number
    1820334-2023-00132
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Report Date
    April 18, 2023
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002574854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: SUPPLY CHAIN SUPERVISOR. PMA/510(K) #: K171853. 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: A REPRESENTATIVE OF (B)(6) HOSPITAL (UNITED STATES) INFORMED COOK ON 10FEB2023 OF AN ISSUE WITH A LIVER ACCESS AND BIOPSY SET (RPN: LABS-100-J-01; LOT #: 15025804). THE CUSTOMER REPORTED THAT THERE WAS A HAIR INSIDE THE SEALED PACKAGING. THE DEVICE WAS UNUSED AND DID NOT MAKE PATIENT CONTACT. NO ADVERSE EFFECTS HAVE BEEN REPORTED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES FOR THE DEVICE, AS WELL AS A VISUAL INSPECTION OF RETURNED PRODUCT, WERE CONDUCTED DURING THE INVESTIGATION. ONE UNUSED/SEALED DEVICE WAS RECEIVED. UPON INSPECTION, A HAIR LIKE FIBER WAS NOTICED INSIDE THE SEALED PACKAGING. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT 15025804 RECORDS NO COMPLAINTS OR NONCONFORMANCES. AN EXPANDED DHR WAS PERFORMED. ADDITIONAL LOTS OF THE SAME RPN WHICH WERE PACKAGED WITHIN THE DATE RANGE OF 12OCT2022 ¿ 07NOV2022 FOR THIS LOT WERE REVIEWED. NO RELATED COMPLAINTS WERE FOUND WITHIN THESE LOTS. WE FOUND RELATED NONCONFORMANCES, BUT THE NONCONFORMING DEVICES WERE SCRAPPED, AND THE ENTIRE LOT UNDERWENT 100% INSPECTION FOR THIS FAILURE. BASED ON THE DMR, DHR, AND DEVICE EVALUATION, THERE IS INDICATION THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN THE FIELD OR IN HOUSE. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_LABS2_REV1] ¿LIVER ACCESS AND BIOPSY SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿HOW SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND 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 INFORMATION PROVIDED, INSPECTION OF THE RETURNED UNUSED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO A MANUFACTURING DEFICIENCY. 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 HAIR-LIKE FIBER WAS DISCOVERED WITHIN THE SEALED PACKAGING OF A LIVER ACCESS AND BIOPSY SET. IT WAS CONFIRMED THAT THE DEVICE DID NOT MAKE PATIENT CONTACT.

    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
    682464 LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 15025804 00827002574854

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown