BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30G 8MM

    MDR report key: 11898834 · Received May 27, 2021

    Report

    Report Number
    1920898-2021-00612
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 30, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K955235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. TWO PHOTOS OF (11) LOOSE 0.3ML SYRINGES WERE PROVIDED. THE CUSTOMER REPORTED THAT THE SCALE ON THE SYRINGES IS OFTEN NOT ACCURATE, SKEWED OR OFFSET. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT 1 OF THE SYRINGES EXHIBITED A DISFIGURED STOPPER. NO DEFECTS RELATED TO THE SCALE MARKINGS COULD BE DETERMINED BASED ON THE 2 PROVIDED PHOTOS ALONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [ NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR SCRATCHED PRINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9176501. 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. THERE WAS ONE (1) NOTIFICATION NOTED FOR SCRATCHED PRINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9266924 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR MISSING PRINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SYRINGE 0.3ML 30G 8MM HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE SCALE ON THE SYRINGES IS OFTEN NOT EXACTLY THE SAME, AT AN ANGLE OR AT AN OFFSET.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 9176501 ¿ DEVICE EXPIRATION DATE : 07/31/2024. DEVICE MANUFACTURE DATE : 06/25/2019. LOT # : 9266924 DEVICE EXPIRATION DATE : 09/30/2024. DEVICE MANUFACTURE DATE : 09/23/2019. LOT # : 0090628 DEVICE EXPIRATION DATE : 04/30/2025 DEVICE MANUFACTURE DATE : 03/30/2020. 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 3 BD SYRINGE 0.3ML 30G 8MM HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE SCALE ON THE SYRINGES IS OFTEN NOT EXACTLY THE SAME, AT AN ANGLE OR AT AN OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793562 SYRINGE 0.3ML 30G 8MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1