BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRYO REPLACEMENT CATHETER, SURE-PRO, WALLACE, + OBTURATOR

    MDR report key: 8720884 · Received June 21, 2019

    Report

    Report Number
    3012307300-2019-03611
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    October 18, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    PBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TWO POUCHES AND ONE INNER TRAY WITH COMPONENTS OF AN EMBRYO REPLACEMENT CATHETER WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE POUCHES FOUND NO EVIDENCE THAT THEY HAD BEEN SEALED. PACKAGING PROCESS CONSISTS OF LOADING OF INNER TRAY WITH COMPONENTS INTO POUCH AND THEN MANUAL SEALING OF OPEN SIDE OF POUCH. BASED ON FACT THAT ON RETURNED SAMPLES THERE WERE NO RESIDUES AFTER THERMOTRANSFER PROCESS IT IS THE MOST PROBABLE THAT THE RETURNED POUCHES WERE OMITTED TO BE SEALED DURING PACKAGING PROCESS. THIS HAS BEEN DETERMINED TO BE THE CAUSE OF ISSUE, AS THE REPORTED CUSTOMER COMPLAINT WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: FOREIGN: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A THE "POCKET" ON A SMITHS MEDICAL EMBRYO REPLACEMENT CATHETER, SURE-PRO, WALLACE, + OBTURATOR "IS NOT CLOSED. NOT STERILIZED". NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516933 EMBRYO REPLACEMENT CATHETER, SURE-PRO, WALLACE, + OBTURATOR EMBRYO IMAGE ASSESSMENT SYSTEM, ASSISTED REPRODUCTION PBH SMITHS MEDICAL ASD, INC. 3509014

    Patients

    Seq Age Sex Outcome Treatment
    1