BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRYO RPLCMNT CATHETER

    MDR report key: 9109224 · Received September 24, 2019

    Report

    Report Number
    1216677-2019-00264
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 3, 2019
    Report Date
    December 23, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQF
    PMA / PMN Number
    K990349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE E-COMPLAINT- (B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-NO SAMPLE RETURNED AND X-REVIEW DHR. THE COMPLAINT PEB623 WAS MANUFACTURED AT CSI ON MAY 17TH, 2019 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW THE DHR- FOR THIS UNIT (ATTACHED) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC-RECORDS FOR THE TUBING (P/N 005/501/000) AND THE SILICONE DEPTH MARKER (P/N 005/501/050) (SEE ATTACHED) WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE ATTACHED 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. A PICTURE WAS SENT THROUGH THE COMPLAINT, THE COMPONENT WAS CONFIRMED TO BE THE SILICONE DEPTH MARKER P/N 005/501050, HOWEVER FROM THE PICTURE IT IS NOT CONCLUSIVE ENOUGH TO CONFIRM ANY DEVIATION PRESENT ON THE COMPONENT. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. ALL MATERIALS USED DURING THE MANUFACTURING OF LOT 2458 COMPLIED WITH THE SPECIFICATIONS. CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. ROOT CAUSE WAS NOT CONFIRMED FOR THIS REASON TRAINING WAS NOT REQUIRED WAS THE COMPLAINT CONFIRMED? NO. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    PATIENT HAD EMBRYO TRANSFER 2.9.19 - PATIENT REPORTED 11:30PM 3.4.19 THAT HAD FOUND SMALL WHITE DISC. IMAGE TAKEN AND IDENTIFIED AS PLASTIC STOPPER FROM SURE-PRO ULTRA CATHETER. REF E-COMPLAINT- (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT (B)(4). PRODUCT #: PEB623. LOT/SERIAL #: (B)(4). FDA 510K#/PMA#/OTHER: K033084+K990350+K990349.

    Description of Event or Problem · 1

    PATIENT HAD EMBRYO TRANSFER (B)(6) 2019 - PATIENT REPORTED 11:30PM (B)(6) 2019 THAT HAD FOUND SMALL WHITE DISC. IMAGE TAKEN AND IDENTIFIED AS PLASTIC STOPPER FROM SURE-PRO ULTRA CATHETER. REF E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907806 EMBRYO RPLCMNT CATHETER EMBRYO RPLCMNT CATHETER MQF COOPERSURGICAL, INC. PEB623 -

    Patients

    Seq Age Sex Outcome Treatment
    1 Other