BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8499303 · Received April 10, 2019

    Report

    Report Number
    1213809-2019-00426
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052746
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THREE PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICT PRODUCT PACKAGING FOR INTEGRA BATCH #8002924,(B)(4). SINCE NO SAMPLES, INCLUDING PHOTOS, DISPLAYING THE REPORTED CONDITION HAVE BEEN RECEIVED FOR EVALUATION NO DEFECTS COULD BE CONFIRMED. PLEASE NOTE THAT INTEGRA PRODUCT HAS A RETRACTABLE NEEDLE FEATURE PER PRODUCT DESIGN. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305274 BATCH NO.: 8002924 . IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE PART SEPARATED FROM THE SYRINGE. VERBATIM: I AM REACHING OUT TO YOU TODAY BECAUSE I WANTED TO LET SOMEONE KNOW ABOUT MY EXPERIENCE USING ONE OF YOUR PRODUCTS; THE BD INTEGRA NEEDLES/SYRINGES. I WAS ATTEMPTING TO INJECT MY PRESCRIPTION MEDICATION LAST WEEK AND WHILE DOING SO THE ENTIRE SYRINGE SEIZED UP AND THE NEEDLE PART LITERALLY SHOT ACROSS THE ROOM AND SEPARATED FROM THE SYRINGE. I HAVE NEVER SEEN ANYTHING LIKE IT. WHILE I WAS NOT HARMED IN THIS PROCESS IT SCARED ME AND I HAVE YET TO FIND THE NEEDLE TIP. NOW I AM CONSTANTLY WORRIED ABOUT STEPPING/SITTING ON IT. AND INJURING MYSELF. I WILL NOT BE USING THE REMAINING SYRINGES BECAUSE THIS SCARED ME TOO MUCH. I WORK WITH PRODUCTS AND QUALITY CONTROL AND SUCH SO I FELT IT WAS IMPORTANT SOMEONE KNEW ABOUT THIS. THE PRODUCT INFORMATION FROM THE PACKAGING IS INCLUDED IN THE PHOTOS. I DISPOSED OF THE REST OF THE SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305274, BATCH NO.: 8002924. IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE PART SEPARATED FROM THE SYRINGE. VERBATIM: I AM REACHING OUT TO YOU TODAY BECAUSE I WANTED TO LET SOMEONE KNOW ABOUT MY EXPERIENCE USING ONE OF YOUR PRODUCTS; THE BD INTEGRA NEEDLES/SYRINGES. I WAS ATTEMPTING TO INJECT MY PRESCRIPTION MEDICATION LAST WEEK AND WHILE DOING SO THE ENTIRE SYRINGE SEIZED UP AND THE NEEDLE PART LITERALLY SHOT ACROSS THE ROOM AND SEPARATED FROM THE SYRINGE. I HAVE NEVER SEEN ANYTHING LIKE IT. WHILE I WAS NOT HARMED IN THIS PROCESS IT SCARED ME AND I HAVE YET TO FIND THE NEEDLE TIP. NOW I AM CONSTANTLY WORRIED ABOUT STEPPING/SITTING ON IT. AND INJURING MYSELF. I WILL NOT BE USING THE REMAINING SYRINGES BECAUSE THIS SCARED ME TOO MUCH. I WORK WITH PRODUCTS AND QUALITY CONTROL AND SUCH SO I FELT IT WAS IMPORTANT SOMEONE KNEW ABOUT THIS. THE PRODUCT INFORMATION FROM THE PACKAGING IS INCLUDED IN THE PHOTOS. I DISPOSED OF THE REST OF THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295352 BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE SYRINGE WITH NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 8002924 30382903052746

    Patients

    Seq Age Sex Outcome Treatment
    1 Other