BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10804987 · Received November 6, 2020

    Report

    Report Number
    1920898-2020-01540
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 16, 2020
    Report Date
    April 15, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 # 0083503. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG HUB SEPARATED AND THE PLUNGER ROD WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909 , BATCH NO. 0083503. IT WAS REPORTED THAT WHEN REMOVING THE ORANGE CAP FROM ONE SYRINGE THE WHOLE NEEDLE CAME OFF WITH IT. ALSO, ON A SECOND SYRINGE, THE PLUNGER ROD WAS PULLED DOWN AND THE WHITE PLUNGER CAP WAS MISSING. VERBATIM: CONSUMER REPORTED HAVING WHEN REMOVING THE ORANGE CAP FROM ONE SYRINGE THE WHOLE NEEDLE CAME OFF WITH IT. STATED SHE DID NOT HAVE DIFFICULTY REMOVING THE ORANGE CAP. STATED SHE HAD A SECOND SYRINGE FROM ANOTHER POLY BAG THAT HAD THE PLUNGER ROD PULLED DOWN AS IF YOU WERE TO PULL IT BACK TO DRAW THE MEDICATION. STATED THE WHITE PLUNGER CAP WAS ALSO MISSING FROM THS SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG HUB SEPARATED AND THE PLUNGER ROD WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324909 BATCH NO. 0083503. IT WAS REPORTED THAT WHEN REMOVING THE ORANGE CAP FROM ONE SYRINGE THE WHOLE NEEDLE CAME OFF WITH IT. ALSO, ON A SECOND SYRINGE, THE PLUNGER ROD WAS PULLED DOWN AND THE WHITE PLUNGER CAP WAS MISSING. VERBATIM: CONSUMER REPORTED HAVING WHEN REMOVING THE ORANGE CAP FROM ONE SYRINGE THE WHOLE NEEDLE CAME OFF WITH IT. STATED SHE DID NOT HAVE DIFFICULTY REMOVING THE ORANGE CAP. STATED SHE HAD A SECOND SYRINGE FROM ANOTHER POLY BAG THAT HAD THE PLUNGER ROD PULLED DOWN AS IF YOU WERE TO PULL IT BACK TO DRAW THE MEDICATION. STATED THE WHITE PLUNGER CAP WAS ALSO MISSING FROM THS SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269965 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 0083503 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1