BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 11274017 · Received February 3, 2021

    Report

    Report Number
    1820334-2021-00245
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    February 1, 2021
    Report Date
    May 5, 2021
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002124233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION THE DISTRIBUTOR QINGDAO YUAN BO BILLION TRADE CO., LTD. INFORMED COOK OF AN INCIDENT INVOLVING A PERFORMER INTRODUCER FROM LOT 13415476. THE DEVICE REPORTEDLY HAD A HAIR FOUND INSIDE THE PACKAGING AT THE DISTRIBUTION CENTER ON 1FEB2021. THERE WAS NO IMPACT TO A PATIENT OR END USER. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION OF THE RETUNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT RETURNED ONE PRIOR TO USE RCFN-6.0-18-MPIS-NT TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED A DARK STRAND IN THE SEALED POUCH. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THIS FAILURE WAS FOUND AT THE DISTRIBUTION CENTER SO THE IFU IS NOT AT PLAY, HOWEVER THE IFU DOES STATE: ¿HOW SUPPLIED 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." A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION TO CHECK FOR FAILURE RELATED NONCONFORMANCES AND ADDITIONAL COMPLAINTS. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS RECORDS NO NONCONFORMANCES. A COMPLAINT DATABASE SEARCH REVEALED THIS COMPLAINT TO BE THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT. EVIDENCE FROM THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, MANUFACTURING DOCUMENTS, AND DEVICE FAILURE ANALYSIS SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. HOWEVER, THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, COOK ESTABLISHED MANUFACTURING QUALITY AS THE CAUSE FOR THIS EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK 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.

    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

    PMA/510K #: PREAMENDMENT. 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

    AS REPORTED, THE DISTRIBUTOR NOTED THE PACKAGING OF A PERFORMER INTRODUCER CONTAINED A HAIR-LIKE FIBER. THE PRODUCT WAS NOT AT A USER FACILITY, THEREFORE THERE WAS NO IMPACT TO ANY PATIENT OR END USER. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168736 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G12423 13415476 00827002124233

    Patients

    Seq Age Sex Outcome Treatment
    1