BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 5221060 · Received November 12, 2015

    Report

    Report Number
    1213809-2015-00011
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    November 3, 2015
    Report Date
    August 19, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON 1/18/2016 THE CUSTOMER RETURNED MEDICAL PAPER WORK THAT PROVIDED THE FOLLOWING INFORMATION: AGE AT TIME OF EVENT/DATE OF BIRTH: (B)(6) / (B)(6) 1966. WEIGHT: (B)(6). DESCRIBE EVENT OR PROBLEM: THE PATIENT RECEIVED A TETANUS IMMUNIZATION AND A PRESCRIPTION FOR BACTRIM DS 160-800 MG TO BE TAKEN BY MOUTH EVERY 12 HOURS FOR 10 DAYS. RELEVANT TESTS/LABORATORY DATA: TETANUS IMMUNIZATION, ANTIBIOTICS (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE ALONG WITH AN OPEN BLISTER PACK WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT THE NEEDLE HAD RETRACTED AND WAS INSIDE THE SYRINGE BARREL. BD INTEGRA¿ IS A RETRACTABLE SYRINGE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 3171195. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THE RETURNED SAMPLE AND DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES/NO FAILURE WAS DETECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A PRESCRIPTION FOR BACTRIM DS 160-800 MG TO BE TAKEN BY MOUTH EVERY 12 HOURS FOR 10 DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER USED A BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE FOR AN INJECTION AND THE NEEDLE BROKE OFF IN USE. THE CONSUMER WENT TO A HOSPITAL AND RECEIVED AN ULTRASOUND. THE NEEDLE WAS NOT VISUALIZED. UPON FURTHER EVALUATION OF THE SYRINGE, THE CONSUMER FOUND THAT THE NEEDLE HAD RETRACTED INTO THE BARREL OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749781 BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention