BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    MDR report key: 10214293 · Received June 30, 2020

    Report

    Report Number
    1920898-2020-00772
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063697. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200812524] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE CANNULA WAS TOO LONG. THIS OCCURRED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324911 BATCH NO. 9063697. IT WAS REPORTED THAT NEEDLE LENGTH IS LONGER THAN 6MM. VERBATIM: PHARMACIST CALLED ON BEHALF OF CONSUMER STATING THAT HER PATIENT RETURNED A PACKAGE OF 10 6MM SYRINGES WITH INCORRECT NEEDLE LENGTH. SHE STATED THAT THE NEEDLES ARE LONGER THAN 6MM. THE DESCRIPTION ON THE PLASTIC BAG IS 1/2ML, 6MM, 31G.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE CANNULA WAS TOO LONG. THIS OCCURRED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324911, BATCH NO. 9063697. IT WAS REPORTED THAT NEEDLE LENGTH IS LONGER THAN 6MM. VERBATIM: PHARMACIST CALLED ON BEHALF OF CONSUMER STATING THAT HER PATIENT RETURNED A PACKAGE OF 10 6MM SYRINGES WITH INCORRECT NEEDLE LENGTH. SHE STATED THAT THE NEEDLES ARE LONGER THAN 6MM. THE DESCRIPTION ON THE PLASTIC BAG IS 1/2ML, 6MM, 31G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679587 BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 9063697 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other