BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITH HUBER

    MDR report key: 2306732 · Received September 23, 2011

    Report

    Report Number
    2523676-2011-00124
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 23, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K021488
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE YELLOW FEMALE ADAPTER FROM THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. THE REMAINDER OF THE SET WAS NOT RETURNED. UPON VISUAL OBSERVATION, SOLVENT TRACES WERE EVIDENT INSIDE THE ADAPTER WHICH IS AN INDICATION THAT A BOND BETWEEN THE ADAPTER AND TUBING WAS PRESENT. NO PART OF THE TUBING WAS RETAINED INSIDE THE ADAPTER. THERE WERE NO CRACKS OR STRESS MARKS EVIDENT ON THE ADAPTER. IN ADDITION, THE RETURNED ADAPTER WAS DIMENSIONALLY TESTED AND MET SPECIFICATION. NO ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE HOUSE RETAIN SAMPLES FOR THE REPORTED LOT WERE PULLED FOR EVALUATION. THE RETAINS WERE FUNCTIONALLY TESTED FOR LUER TAPERS, OCCLUSION, WATER PRESSURE, CLAMP PERFORMANCE, AND PULL STRENGTH BETWEEN THE ADAPTER AND TUBING. THE RETAINS MET ALL SPECIFICATIONS AND EXCEEDED THE MINIMUM JOINT SEPARATION (PULL STRENGTH) DESIGN SPECIFICATION OF 4.0LBS. A DHR REVIEW WAS CONDUCTED AND NO ABNORMALITIES IN THE MANUFACTURE OF THE PRODUCT WERE NOTED. A HISTORIC REVIEW OF THE COMPLAINTS DATABASE WAS CONDUCTED AND NO TRENDS WERE IDENTIFIED REGARDING THIS ISSUE FOR THE PART NUMBER OR BATCH NUMBER ASSOCIATED WITH THIS EVENT. WITHOUT THE ENTIRE SAMPLE AVAILABLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. AT THIS STAGE NO SPECIFIC CONCLUSIONS CAN BE DRAWN REGARDING THE CAUSE OF THE EVENT. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: I AM AT THE OFFICE NOW OF DR. (B)(6) WHO'S PATIENT WAS AT HOME LAST NIGHT USING PRODUCT WHEN HE WOKE TO BLOOD EVERYWHERE BLEEDING OUT OF HIM. PATIENT STOPPED BLEEDING BY USING HIS FINGER OR PINCHING TUBING UNTIL HE GOT TO THE EMERGENCY ROOM AND THEY CLAMPED OFF THE BLEEDING. THE PRODUCT WAS USED IN HIS CHEST PORT. THE TUBING WAS PULLED AWAY FROM THE YELLOW PART. THE PATIENT ALMOST BLED TO DEATH. THE PATIENT WAS DISCHARGED FROM EMERGENCY ROOM WITH NO ILL EFFECTS. ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER INDICATES THE PATIENT WAS RECEIVING CHEMO. THE TUBING ALONG WITH THE CLAMP HAD FALLEN OFF WHILE THE PATIENT WAS SLEEPING. THE REPORTER BELIEVES THAT THE PATIENT MAY HAVE BEEN TREATED AT (B)(6) EMERGENCY, BUT IS NOT SURE. THE REPORTER INDICATED THAT THE YELLOW PIECE WAS STILL CONNECTED TO THE PUMP. THE REPORTER BELIEVES THE ER FACILITY DISCARDED THE REST OF THE SET BECAUSE IT INVOLVED A SHARPS. THE REPORTER STATED THEY "TOOK THE NEEDLE AND DIDN'T EVEN FLUSH HIM." THE PATIENT WAS RELEASED FROM THE ER AND TOLD TO REPORT BACK TO HIS DOCTOR IN THE MORNING. NO TRANSFUSION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WITH HUBER WHIN WINGED HUBER NEEDLE 20GX1 FPA B. BRAUN MEDICAL, INC. NA 0061169459

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other