BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 6MM

    MDR report key: 16358497 · Received February 10, 2023

    Report

    Report Number
    1920898-2023-00046
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 19, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-FEB-2023. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (7) SYRINGE 0.5ML 31GA 6MM LOOSE. IT WAS REPORTED BY THE CONSUMER THAT THERE IS A SHARP EDGE UNDER THE THUMB PRESS WHICH CAUSES CUSTOMER TO GET A PAPER-CUT-LIKE CUT. ALL THE SYRINGES WERE EXAMINED USING MAGNIFICATION AND FOUND NO EVIDENCE OF SHARP EDGES TO THE PLUNGER THUMB PRESS THAT COULD LEAD TO CUT. HENCE, THE ALLEGED ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURN FOR THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090596. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. ROOT CAUSE IS NOT DETERMINED AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 6MM THERE WAS A SHARP PROTRUSION ON THE PLUNGER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THERE IS A SHARP EDGE UNDER THE THUMB PRESS ON THE PLUNGER ROD. HE STATED THAT HE GETS CUT WHEN HE PULLS THE PLUNGER ROD OUT, STATED THAT THE CUT IS SIMILAR TO A PAPER CUT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 6MM THERE WAS A SHARP PROTRUSION ON THE PLUNGER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THERE IS A SHARP EDGE UNDER THE THUMB PRESS ON THE PLUNGER ROD. HE STATED THAT HE GETS CUT WHEN HE PULLS THE PLUNGER ROD OUT, STATED THAT THE CUT IS SIMILAR TO A PAPER CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48572 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 0090596 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown