BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 11098532 · Received December 30, 2020

    Report

    Report Number
    1920898-2020-01779
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 2, 2020
    Report Date
    March 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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: 2021-03-18. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED FOUR SYRINGES WITH NO POUCH FOR IDENTIFICATION. THE GRADUATION MARKS ON THE SYRINGES INDICATE THAT THEY ARE 0.3ML VOLUME SYRINGES. FOR ALL SYRINGES, THE NEEDLE HUBS HAVE SEPARATED FROM THE BARREL. THE HUBS ARE LODGED IN THEIR RESPECTIVE NEEDLE SHIELD. THERE IS NO DAMAGE TO THE CONNECTORS AT THE DISTAL TIPS OF THE BARRELS OR THE BASES OF THE NEEDLE HUBS. PLUNGER CAPS HAVE BEEN REMOVED BUT THERE ARE NO SIGNS OF USE. NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0132200 AND 0062057 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR OUT OF SPEC SHIELD PULLS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT FOR BATCH# 0062057. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BOXES OF SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED WHEN THE SHIELDS WERE REMOVED. ALSO, THE SHIELDS ARE DIFFICULT TO REMOVE. VERBATIM: CONSUMER STATED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELDS STATED, SHIELDS ARE DIFFICULT TO REMOVE ON A LOT OF HER SYRINGES STATED, SHE HAD TWO BOXES THAT WERE AFFECTED".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0062057, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, MEDICAL DEVICE LOT #:0132200. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. DEVICE MANUFACTURE DATE: 2020-05-11. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BOXES OF SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED WHEN THE SHIELDS WERE REMOVED. ALSO, THE SHIELDS ARE DIFFICULT TO REMOVE. VERBATIM: CONSUMER STATED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELDS STATED, SHIELDS ARE DIFFICULT TO REMOVE ON A LOT OF HER SYRINGES STATED, SHE HAD TWO BOXES THAT WERE AFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562267 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 SEE H.10. 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1