BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 ML FILL IN 10 ML DIAMETER BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE

    MDR report key: 6099738 · Received November 14, 2016

    Report

    Report Number
    1911916-2016-00023
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 10, 2016
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL REPORTER, STERICYCLE EXPERT SOLUTIONS, PROVIDED AN INCIDENT REPORT TO BD, THE MOTHER OF THE AFFECTED PATIENT PROVIDED BD WITH UPDATED DEVICE INFORMATION, CATALOG, AND LOT NUMBERS. TWO SEPARATE LOT NUMBERS WERE USED FOR THIS INCIDENT. THE INFORMATION FOR THESE LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5361888, MEDICAL DEVICE EXPIRATION DATE: 11/30/2018, DEVICE MANUFACTURING DATE: 12/27/2015. MEDICAL DEVICE LOT #: 6011624, MEDICAL DEVICE EXPIRATION DATE: 12/31/2018, DEVICE MANUFACTURING DATE: 1/11/2016. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS AND STERILIZATION RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS 5361888 AND 6011624. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTHER OF A (B)(6) PATIENT WITH CEREBRAL PALSY USED 10 ML FILL IN 10 ML DIAMETER BD POSIFLUSH" NORMAL SALINE FILLED SYRINGES, PURCHASED FROM EAST DEALS AND TREASURE ZONE THROUGH AMAZON, TO ADMINISTER MEDICATIONS TO HER DAUGHTER. AFTER USING THE SYRINGES THE PATIENT BECAME ILL WITH VOMITING, EXPLOSIVE GAS, AND DIARRHEA. THE PATIENT WAS SEEN BY HER PHYSICIAN AND BASIC BLOOD TESTS, EVALUATION OF HER SEIZURE MEDICATION LEVELS, AND A GLUTEN WHEAT TEST WERE PERFORMED. THE PATIENT WAS ALSO GIVEN PRILOSEC, WHICH ONLY HELPED FOR THREE DAYS, AND AN UPPER ENDOSCOPY WAS SCHEDULED FOR (B)(6) 2016. THE RESULTS OF THESE TESTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750286 10 ML FILL IN 10 ML DIAMETER BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE FLUSH SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention