BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD U-100 INSULIN SYRINGE SLIP TIP WITH PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7535453 · Received May 22, 2018

    Report

    Report Number
    1213809-2018-00294
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 30, 2018
    Report Date
    June 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE EVALUATION: ONE OPEN 1ML PACKAGED SYRINGE WITH NEEDLE WAS RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7031975 (P/N 329622). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE A BROKEN SYRNGE TIP. THE TIP IS ABOUT 95% DISCONNECTED FROM THE SYRINGE BODY. THE TOP WEB OF THE PACKAGE APPEARS TO HAVE BEEN RIPPED OPENED FROM THE SAME LOCATION - ABOUT 2/3 OF THE WAY UP THE PACKAGE, INSTEAD OF THE AT THE PEEL TAB. THE LOCATION COINCIDES WITH THE POSITION OF THE TIP ON THE SYRINGE. IT APPEARS THE PRODUCT WAS DAMAGED AFTER IT WAS PACKAGED AND SEALED. BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CAN BE VERIFIED. DHR REVIEW FOR BATCH 7031975 (P/N 329622): MANUFACTURING DATES: 02/10/2017 TO 02/11/2017. BATCH QUANTITY WAS 352,800. ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7031975 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ROOT CAUSE AND CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HUB ON A BD 1ML U-100 INSULIN SYRINGE SLIP TIP WITH PRECISIONGLIDE¿ NEEDLE WAS FOUND DAMAGED PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378256 BD U-100 INSULIN SYRINGE SLIP TIP WITH PRECISIONGLIDE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 7031975

    Patients

    Seq Age Sex Outcome Treatment
    1 Other