BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE

    MDR report key: 14799671 · Received June 24, 2022

    Report

    Report Number
    1920898-2022-00409
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 24, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL? YES. D9: RETURNED TO MANUFACTURER ON: 27-JUN-2022. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (1) LOOSE 0.5ML BD INSULIN SYRINGE FROM LOT# 2010787. THE CUSTOMER REPORTED THAT THE NEEDLE HUB ASSEMBLY REMOVED WITH THE SHIELD FROM 1 SYRINGE. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2010787. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE THAT WHEN SHIELD WAS REMOVED THE NEEDLE HUB SEPARATED WITH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WHEN REMOVED NEEDLE SHIELD FROM SYRINGE THE NEEDLE HUB ASSEMBLY REMOVED WITH THE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE THAT WHEN SHIELD WAS REMOVED THE NEEDLE HUB SEPARATED WITH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE WHEN REMOVED NEEDLE SHIELD FROM SYRINGE THE NEEDLE HUB ASSEMBLY REMOVED WITH THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277103 BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE 324911 2010787 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown