BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 29G 12.7MM 10BAG 500 EU

    MDR report key: 10776158 · Received November 2, 2020

    Report

    Report Number
    1920898-2020-01516
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 13, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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# 9182218. ALL INSPECTIONS 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 THE SYRINGE 1ML 29G 12.7MM 10BAG 500 EU EXPERIENCED DIFFICULTY MOVING THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT ABOUT THE BD MICRO-FINE + INSULIN SYRINGE U100 1ML 29G YESTERDAY USED THE NEW BD MICRO FINE SYRINGES. PROBLEM THAT THE PLUNGERS ARE JAMMING. SYRINGES WITH PLUNGER FIRST MOVED BACK AND FORTH WELL. FILLING THE SYRINGES IS DIFFICULT AND THE SYRINGE CAN ONLY BE EMPTIED WITH ENORMOUS PRESSURE ON THE PLUNGER. INFORMATION FROM THE CUSTOMER: REF. 324827, LOT 9182218.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1ML 29G 12.7MM 10BAG 500 EU EXPERIENCED DIFFICULTY MOVING THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT ABOUT THE BD MICRO-FINE + INSULIN SYRINGE U100 1ML 29G YESTERDAY USED THE NEW BD MICRO FINE SYRINGES. PROBLEM THAT THE PLUNGERS ARE JAMMING. SYRINGES WITH PLUNGER FIRST MOVED BACK AND FORTH WELL. FILLING THE SYRINGES IS DIFFICULT AND THE SYRINGE CAN ONLY BE EMPTIED WITH ENORMOUS PRESSURE ON THE PLUNGER. INFORMATION FROM THE CUSTOMER: REF. 324827, LOT 9182218.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239140 SYRINGE 1ML 29G 12.7MM 10BAG 500 EU SYRINGE FMF BD MEDICAL - DIABETES CARE 9182218

    Patients

    Seq Age Sex Outcome Treatment
    1