BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10685397 · Received October 15, 2020

    Report

    Report Number
    1920898-2020-01410
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: 2020-10-23 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED TWO (2) LOOSE 31GX6MM, 0.3ML BD INSULIN SYRINGES. CONSUMER STATED 1 SYRINGE WOULD NOT DRAW HER INSULIN, AND THAT THERE WERE ONLY 9 BAGS INSTEAD OF 10 BAGS IN THE NEW BOX. THE RETURNED SYRINGES WERE EXAMINED, THEN TESTED FOR FLOW: BOTH SYRINGES WERE ABLE TO DRAW AND EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECT WAS OBSERVED, THE ALLEGED ¿NOT DRAWING¿ ISSUE COULD NOT BE CONFIRMED. FURTHERMORE, THE CUSTOMER DID NOT RETURN THE SHELF CARTON OR POLYBAGS, THEREFORE, THE ALLEGED INCORRECT COUNT (LESS POLYBAGS) ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200845676, 200845567, 200845495] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CONSUMER STATED, 1 SYRINGE WOULD NOT DRAW HER INSULIN. COULD NOT USE STATED, PURCHASED A BOX FROM PHARMACY AND WHEN SHE GOT HOME, THERE WERE ONLY 9 BAGS INSTEAD OF 10 BAGS IN THE NEW BOX."

    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 ONE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "CONSUMER STATED, 1 SYRINGE WOULD NOT DRAW HER INSULIN. COULD NOT USE STATED, PURCHASED A BOX FROM PHARMACY AND WHEN SHE GOT HOME, THERE WERE ONLY 9 BAGS INSTEAD OF 10 BAGS IN THE NEW BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152679 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other