BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 9755924 · Received February 26, 2020

    Report

    Report Number
    2210968-2020-01510
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    January 15, 2020
    Report Date
    February 3, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/8/2020. CORRECTION: D2, D2B, G1, G2, G5.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION HAVE BEEN MADE WITH NO RESPONSE TO DATE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PROCEDURE NAME. PROCEDURE DATE. DATE OF EVENT? PRODUCT CODE AND LOT NUMBER? THE PROVIDED CODE: J1245 AND LOT: E180820 ARE NOT ETHICON PRODUCT/LOT, PLEASE ADVISE? WAS THE DRAIN BROKEN DURING REMOVAL AFTER COMPLETION OF ITS USE? LOCATION AND SIZE OF THE DRAIN PIECE RETAINED IN PATIENT? HOW WAS DRAIN SECURED? WERE ANY ANOMALIES NOTED OF THE DRAIN CONDITION UPON PLACEMENT? DID THE DRAIN COME IN CONTACT WITH SHARP OBJECTS AT ANY TIME: SURGICAL INSTRUMENTS, SURGICAL NEEDLES, SUTURES,? DID THE DRAIN FUNCTION AS INTENDED? WAS THE RETAINED PIECE REMOVED FROM THE PATIENT SURGICALLY? ARE ANY PLANS IN PLACE THE REMOVE THE DRAIN PIECE IN FUTURE? DATE? ARE THERE ANY OTHER ADVERSE PATIENT CONSEQUENCES DUE TO THIS ISSUE AND HOW WERE THEY TREATED? IF SUCTION WAS NOT COMPLETED, WAS A NEW DRAIN INSERTED IN THE PATIENT? PLEASE PROVIDE PATIENT DEMOGRAPHIC INFORMATION: AGE, GENDER, WEIGHT, BMI AT THE TIME OF THE INDEX PROCEDURE? WHAT IS THE CURRENT STATUS OF THE PATIENT? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS OF THIS EVENT? TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. ON (B)(6) 2020, WHEN TRYING TO REMOVE THE DRAIN ACCORDING TO MEDICAL PRESCRIPTION, A SLIGHT RESISTANCE WAS FELT, PERFORMED A MASSAGE IN PLACE, IT IS EVIDENT THAT THE DRAIN LEFT AROUND 10CM FROM THE CAVITY AND HAD NEW RESISTANCE. THE DRAIN REMOVED AFTER TRACTION. IT IS EVIDENCED THAT THE TIP OF THE CATHETER WAS RETAINED INSIDE THE LUMBAR CAVITY, AFTER REQUESTED X-RAY OF THE LUMBAR REGION, EVIDENCING THAT PART OF THE DRAIN IS IN THE LUMBAR CAVITY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221592 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention