BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 6137615 · Received December 1, 2016

    Report

    Report Number
    1820334-2016-01352
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    October 30, 2016
    Report Date
    August 17, 2017
    Manufacturer
    COOK INC
    Product Code
    OQY
    UDI-DI
    10827002242378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: THE COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS WAS NOT RETURNED/RECEIVED FOR AN EVALUATION. AS REPORTED BY THE CUSTOMER, THE DEVICE WAS DISCARDED AT THE USER FACILITY. THE REPORTED BALLOON LEAK COULD ONLY BE CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. BASED ON THE INFORMATION AVAILABLE A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THERE WERE NO NON-CONFORMANCES IDENTIFIED DURING THE MANUFACTURING PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PRODUCT ISSUE. A REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT AND LOT NUMBER COMBINATION REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THIS LOT NUMBER. PER THE QUALITY ENGINEERING RISK ASSESSMENT; NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND THE WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OPERATOR PLACED THE BALLOON IN THE PATIENT, WHEN THEY BEGAN INJECTING THE SALINE, FOUND THE BALLOON WAS BROKEN AND LEAKING, THEN THE BALLOON WAS REMOVED AND ANOTHER NEW ONE WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787991 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC N/A 10827002242378

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR