BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE

    MDR report key: 10743067 · Received October 27, 2020

    Report

    Report Number
    1213809-2020-00747
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. DHR REVIEW: RELEASE DATE: 9/10/2019. RELEASED QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9234142 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. RATIONALE: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED CORRECTIVE ACTIONS ARE NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE CAP ON THE BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE DURING USE, THE NEEDLE PIERCED THROUGH IT AND STUCK THE USER'S LEFT MIDDLE FINGER. A PHYSICIAN LOOKED OVER THE NEEDLE STICK INJURY, AND BLOOD WORK WAS ADVISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GIVING A PATIENT A FLU VACCINE AND AFTER SHE FINISHED SHE WAS PLACING THE CAP BACK ON THE NEEDLE. THE NEEDLE WAS INSIDE THE CAP BUT WHEN SHE ADDED PRESSURE TO THE CAP, THE NEEDLE CAME THROUGH THE SIDE OF THE CAP AND PUNCTURED HER ON THE LEFT MIDDLE FINGER." "HAD PHYSICIAN SHE WORKS FOR LOOK AT HER FINGER." "WORKMAN'S COMP HAS ADVISED SHE HAVE BLOODWORK DONE TO TEST FOR HEP B C AND HIV"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208905 BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309623 9234142 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention