BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 13541253 · Received February 16, 2022

    Report

    Report Number
    1920898-2022-00105
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 8, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. 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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-02-16. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A SINGLE 0.5ML SYRINGE WITH NO FURTHER IDENTIFICATION. THE THUMBPRESS AT THE BASE OF THE PLUNGER ROD HAD BROKEN OFF AT THE PLUNGER ROD¿S BASE. VISUAL INSPECTION OF THE FRACTURE PROFILE FOUND A STRESS MARK ACROSS THE THUMB PRESS THAT WAS PERPENDICULAR TO A RIDGE OF MATERIAL FROM THE PLUNGER ROD. BASED ON THIS DAMAGE, IT IS BELIEVED THAT A HIGH STRESS PLACED ACROSS THE THUMBPRESS RESULTED IN THE THUMBPRESS TEARING AWAY FROM THE PLUNGER ROD AT ITS BASE. THE SYRINGE COULD NOT BE USED IN THIS CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1200429. 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. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SYRINGE BEING DIFFICULT TO OPERATE AS THE PLUNGER ROD¿S THUMBPRESS HAD BROKEN OFF. THE ROOT CAUSE OF THE THUMPRESS APPEARS TO BE HIGH STRESSES PLACED ACROSS THE END OF THE PLUNGER ROD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HAD PRODUCT DAMAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE WHITE CIRCULAR DISC AT THE BOTTOM OF THE PLUNGER BROKE OFF DURING USE AND STATED WAS UNABLE TO DISPENSE MEDICATION AS A RESULT. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE HAD PRODUCT DAMAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE WHITE CIRCULAR DISC AT THE BOTTOM OF THE PLUNGER BROKE OFF DURING USE AND STATED WAS UNABLE TO DISPENSE MEDICATION AS A RESULT. DATE OF EVENT : UNKNOWN, SAMPLES : AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528819 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1200429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown