BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA ACCESS EMBRYO TRANSFER CATHETER

    MDR report key: 11754397 · Received April 30, 2021

    Report

    Report Number
    1820334-2021-01263
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 14, 2021
    Report Date
    August 16, 2021
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002347830
    PMA / PMN Number
    K173686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. 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

    EVENT SUMMARY: COOK WAS INFORMED OF AN INCIDENT INVOLVING A GUARDIA ACCESS EMBRYO TRANSFER CATHETER. REPORTEDLY, ONE OF THE 5 DEVICES IN THE PATIENT REFERENCE NUMBER (BUBBLE EFFECT) HAS FOREIGN MATTER. THE CUSTOMER DESCRIBED IT AS A ¿SMALL BUMP" IN THE TRANSFER CATHETER NEAR THE HUB. THE FOREIGN MATTER WAS NOTICED AFTER FLUSHING WITH COOK SYDNEY IVF GAMETE BUFFER MEDIA. THE PROCEDURE WAS COMPLETED BY USING NEW DEVICE. NO ADVERSE EFFECTS WERE REPORTED. INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT-BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE COMPLAINANT RETURNED 5 GUARDIA ACCESS EMBRYO TRANSFER CATHETERS. ALL 5 DEVICES RETURNED FOR PATIENT REFERENCE (B)(6) EXAMINED UNDER MICROSCOPE. ONE DEVICE APPEARS TO HAVE A SOLID SUBSTANCE INSIDE THE HUB, COULD BE POSSIBLY HUB MATERIAL SCRAPED OFF. ALL OTHER DEVICES HAVE FLUID INSIDE. TIPS ARE ROUND AND SMOOTH. NO ISSUE WITH GUIDE CATHETERS. ADDITIONAL INVESTIGATION WAS CONDUCTED ON (B)(6) 2021: ADDITIONAL PHOTOS WERE TAKEN OF THE SOLID SUBSTANCE INSIDE ONE OF THE TRANSFER CATHETER HUBS. ATTEMPTED TO DISLODGE FOREIGN MATTER BY BLOWING OUT WITH AIR, BUT IT COULD NOT BE DISLODGED. HUBS OF OTHER 4 TRANSFER CATHETERS WERE INSPECTED AND THERE WAS NO FURTHER SOLID SUBSTANCE NOTED. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS ONE OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND ONE NON-CONFORMANCES POTENTIALLY RELATED TO THE REPORTED FAILURE MODE, AS SURFACE DEFECTS ON THE TRANSFER CATHETERS WERE IDENTIFIED. THESE NONCONFORMANCES WERE SCRAPPED PRIOR TO DISTRIBUTION. BASED ON THE INDIVIDUAL NATURE OF THE MANUFACTURING PROCESS OF THE TRANSFER CATHETERS, AND EVIDENCE OF SURFACE DEFECTS IDENTIFIED AND SCRAPPED PRIOR TO DISTRIBUTION, IT IS UNLIKELY THIS ISSUE AFFECTS THE ENTIRE LOT. ONE OF THE FIVE RETURNED OPENED COMPLAINT TRANSFER CATHETER RETURNED WITH WAS RETURNED WITH UNIDENTIFIED SUBSTANCE INSIDE OF THE HUB WHEN VIEWED UNDER MICROSCOPE. THE SOLID SUBSTANCE COULD NOT BE DISLODGED WHEN BLOWN OUT. THE UNIDENTIFIED SUBSTANCE APPEARS LIKE THE HUB MATERIAL HAS BEEN SCRAPED AWAY INSIDE OF THE HUB. BASED ON THE AVAILABLE EVIDENCE, A DEFINITIVE CAUSE OF THE UNIDENTIFIED SUBSTANCE COULD NOT BE DETERMINED. IT IS POSSIBLE THE UNIDENTIFIED SUBSTANCE IS A MATERIAL IMPERFECTION OR MATERIAL THAT WAS SCRAPED AWAY EITHER DURING THE MANUFACTURING PROCESS OR BY THE CUSTOMER DURING USE (IF THE SYRINGE USED HAD A SHARP TIP). THEREFORE, IT CANNOT BE DETERMINED IF THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6): THE CUSTOMER DESCRIBED THE FOREIGN MATTER AS A "SMALL BUMP" AND IT WAS NOTED IN THE TRANSFER CATHETER OF THE SET. THE FOREIGN MATTER WAS NOTED NEAR THE DEVICE HUB. THE FOREIGN MATTER WAS NOTICED AFTER FLUSHING THE DEVICE WITH COOK SYDNEY IVF GAMETE BUFFER MEDIA.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    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, FOREIGN MATTER WAS FOUND INSIDE A GUARDIA ACCESS EMBRYO TRANSFER CATHETER BEFORE THE DEVICE WAS TO BE USED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647872 GUARDIA ACCESS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G34783 13674867 00827002347830

    Patients

    Seq Age Sex Outcome Treatment
    1