BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE 6MM X 31G NEEDLE

    MDR report key: 11140999 · Received January 8, 2021

    Report

    Report Number
    1920898-2020-01804
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 11, 2020
    Report Date
    February 11, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 2021-02-10. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) LOOSE 0.3ML BD INSULIN SYRINGES. CONSUMER REPORTED WHEN REMOVING THE ORANGE CAP AND THE WHOLE NEEDLE COMPONENT CAME OFF AND STAYED IN THE CAP. ALL 3 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT EACH SYRINGE EXHIBITED A NEEDLE HUB/SHIELD ASSEMBLY SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0020548 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN REMOVING CAP FROM BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN REMOVING THE ORANGE CAP AND THE WHOLE NEEDLE COMPONENT CAME OFF AND STAYED IN THE CAP. STATED THIS HAPPENED WITH ONE SYRINGE.

    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. FDA DEVICE PROBLEM CODE(S): (B)(4). FDA PATIENT PROBLEM CODE(S): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN REMOVING CAP FROM BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WHEN REMOVING THE ORANGE CAP AND THE WHOLE NEEDLE COMPONENT CAME OFF AND STAYED IN THE CAP. STATED THIS HAPPENED WITH ONE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34887 BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE 6MM X 31G NEEDLE PISTON SYRING FMF BD MEDICAL - DIABETES CARE 0020548

    Patients

    Seq Age Sex Outcome Treatment
    1