BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE

    MDR report key: 1013309 · Received March 14, 2008

    Report

    Report Number
    1213809-2008-00003
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    October 30, 2007
    Report Date
    March 14, 2008
    Manufacturer
    BECTON DICKINSON DIVISION
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULT: "SYRINGE BARREL CRACKED." EVALUATION SUMMARY: A VISUAL INSPECTION OF THE THREE RETURNED SYRINGES (ONE USED AND TWO UNUSED) CONFIRMED LONGITUDINAL CRACKS ON THE BARRELS RANGING FROM ONE TO TWO INCHES IN LENGTH. NO EVIDENCE OF IMPACT OR OTHER DAMAGE WAS OBSERVED. IT IS NOT POSSIBLE TO DETERMINE IF THE CRACKS OCCURRED DURING MANUFACTURING, SHIPPING OR AS A RESULT OF USER TECHNIQUE. AS OF THIS DATE, THERE HAVE BEEN NO OTHER REPORTS FOR INCIDENTS OF THIS NATURE FOR THIS PRODUCT LOT. REPORTS OF CRACKED BARRELS ON 10ML SYRINGE PRODUCTS CURRENTLY OCCUR AT A RATE OF LESS THAN 1 IN 10,000,000 UNITS SHIPPED. ALTHOUGH THE RATE OF OCCURRENCE OF CRACKED BARRELS IN THE FIELD AND DURING OUR MANUFACTURING PROCESS IS QUITE LOW, CONTINUOUS IMPROVEMENT EFFORTS TO FURTHER REDUCE THE OCCURRENCE OF CRACKED BARRELS HAVE BEEN UNDERTAKEN. AS IN ALL INSTANCES, REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR COMPLAINT LEVELS IN ORDER TO IDENTIFY ANY CHANGES IN TRENDING.

    Description of Event or Problem · 1

    PT IS IN A HOME DIALYSIS PROGRAM WHICH IS DONE OVERNIGHT WHILE HE SLEEPS. PT WOKE AND FELT DIZZY. HE WENT TO TURN OFF THE UF (ULTRA FILTRATION) BUTTON AND FOUND THE AREA WET WITH BLOOD. HE CLAIMED THE SYRINGE CRACKED AND BLOOD WAS SEEPING THROUGH IT. PT ESTIMATED THAT APPROX 750 ML OF BLOOD WAS LOST. THE PT CALLED THE NOCTURNAL NURSE TO REPORT THE INCIDENT AND SHE RECOMMENDED HE GO TO THE ER THE NEXT DAY TO BE CHECKED. HE WENT TO THE ER IN THE MORNING AND HIS PRIMARY CARE DOCTOR RELEASE HIM AT 10:30 THAT SAME MORNING. HIS HEMOGLOBIN WAS 13 AND VITALS WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LUER-LOK DISPOSABLE SYRINGE 10 ML SYRINGE WITH 20G X 1" NEEDLE FMF BECTON DICKINSON DIVISION 7002887

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other