BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 1/2IN UF

    MDR report key: 11912365 · Received June 1, 2021

    Report

    Report Number
    1920898-2021-00619
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-05-24. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 0.3ML BD INSULIN SYRINGE WITH AN OPENED POLYBAG FROM LOT# 0335562. CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED AND WAS STUCK INSIDE OF THE SHIELD. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE SYRINGE BARREL TIP WAS BROKEN AND LODGED INSIDE THE CANNULA HUB / SHIELD ASSEMBLY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0335562 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200925794] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BARREL TIP BROKEN). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 0.3ML 30GA 1/2IN UF HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED AND WAS STUCK INSIDE OF THE SHIELD. DATE OF EVENT : UNKNOWN. SAMPLES: AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD SYRINGE 0.3ML 30GA 1/2IN UF HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED AND WAS STUCK INSIDE OF THE SHIELD. DATE OF EVENT : UNKNOWN. SAMPLES: AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812017 SYRINGE 0.3ML 30GA 1/2IN UF PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0335562

    Patients

    Seq Age Sex Outcome Treatment
    1