BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500

    MDR report key: 10182051 · Received June 22, 2020

    Report

    Report Number
    1920898-2020-00711
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 9, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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# 9161989. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLES ARE DULL AND WILL NOT PENETRATE HIS INJECTION SITE VERBATIM: CONSUMER REPORTED, NEEDLES ARE DULL AND WILL NOT PENETRATE HIS INJECTION SITE STATED, FOR THE ONES THAT DO, THEY HURT STATED, SOME OF THE NEEDLES, APPEAR TO HAVE SOMETHING ON THE TIP OF THEM CAUSING THE PAIN WHEN HE INJECTS NO INJURY TO REPORT. DOES NOT RE-USE AND ROTATES INJECTION SITE. LOT: 9161989. CATALOG: 328440. DATE OF EVENT: UNKNOWN. SAMPLES AVAILABLE CL".

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLES ARE DULL AND WILL NOT PENETRATE HIS INJECTION SITE. CONSUMER REPORTED, NEEDLES ARE DULL AND WILL NOT PENETRATE HIS INJECTION SITE STATED, FOR THE ONES THAT DO, THEY HURT STATED, SOME OF THE NEEDLES, APPEAR TO HAVE SOMETHING ON THE TIP OF THEM CAUSING THE PAIN WHEN HE INJECTS NO INJURY TO REPORT. DOES NOT RE-USE AND ROTATES INJECTION SITE. LOT: 9161989. CATALOG: 328440. DATE OF EVENT: UNKNOWN. SAMPLES AVAILABLE CL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641463 SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328440 9161989 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other