BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS

    MDR report key: 11975827 · Received June 10, 2021

    Report

    Report Number
    1820334-2021-01494
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Report Date
    January 27, 2022
    Manufacturer
    COOK INC
    Product Code
    OQY
    PMA / PMN Number
    K170622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: AS REPORTED, DURING TREATMENT OF A POSTPARTUM HEMORRHAGE, A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS COULD NOT BE INFLATED. WHEN THE USER ATTEMPTED TO INFLATE THE BALLOON, THE BALLOON COULD NOT BE FILLED. THE SYRINGE THEN BROKE OFF INSIDE THE STOPCOCK. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION - EVALUATION : REVIEWS OF INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL DATA WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A REVIEW OF COMPLAINT HISTORY RECORDS COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED: "UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." THE COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. REVIEW OF THE CUSTOMER TESTIMONY AND RELEVANT MANUFACTURING DOCUMENTS DOES NOT INDICATE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATIONS AND DOES NOT SUGGEST ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE ARE NONCONFORMING. COOK COULD NOT DETERMINE A DEFINITIVE CAUSE OF THE REPORTED EVENT FROM THE AVAILABLE INFORMATION. THE HAZARD ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. WE 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

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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

    IT WAS REPORTED THAT DURING TREATMENT OF A POSTPARTUM HEMORRHAGE, A COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS COULD NOT BE INFLATED. WHEN THE USER ATTEMPTED TO INFLATE THE BALLOON, THE BALLOON COULD NOT BE FILLED. THE SYRINGE THEN BROKE OFF INSIDE THE STOPCOCK. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY, AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873098 COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS OQY INTRAUTERINE BALLOON OQY COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female