BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA

    MDR report key: 11127861 · Received January 6, 2021

    Report

    Report Number
    1920898-2020-01800
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 9, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. ONE PHOTO OF 1 LOOSE 0.3ML BD INSULIN SYRINGE WAS PROVIDED. THE CUSTOMER REPORTED WHEN HE REMOVES THE SAFETY SHIELD (ORANGE COVER), THE NEEDLE LOOSES FROM THE SYRINGE BODY (TOGETHER WITH THE PLASTIC PART), GETTING STUCK IN THE ORANGE SHIELD. THE PHOTO WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231312. ALL INSPECTIONS AND CHALLENGES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(4) SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IN THE LAST BATCH PURCHASED, WHEN HE REMOVES THE SAFETY SHIELD (ORANGE COVER), THE NEEDLE LOOSES FROM THE SYRINGE BODY (TOGETHER WITH THE PLASTIC PART), GETTING STUCK IN THE ORANGE SHIELD. IT OCCURRED IN (B)(4) SYRINGES FROM THE SAME BATCH. HAS OCCURRED IN 2017 TOO."

    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. INITIAL REPORTER PHONE: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IN THE LAST BATCH PURCHASED, WHEN HE REMOVES THE SAFETY SHIELD (ORANGE COVER), THE NEEDLE LOOSES FROM THE SYRINGE BODY (TOGETHER WITH THE PLASTIC PART), GETTING STUCK IN THE ORANGE SHIELD. IT OCCURRED IN 3 SYRINGES FROM THE SAME BATCH. HAS OCCURRED IN 2017 TOO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19892 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231312

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR