BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 8MM 90 BX 450 MO

    MDR report key: 8983184 · Received September 10, 2019

    Report

    Report Number
    1920898-2019-00958
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282906
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED TWO (2) LOOSE 31G X 8MM, 0.5ML BD INSULIN SYRINGES FROM LOT 8162537. CONSUMER REPORTED INSULIN RUNNING DOWN FROM THE NEEDLE ON SKIN SIGHT DURING THE INJECTION. HE CLARIFIED AND STATED INSULIN CAME OUT DURING THE INJECTION. THE TWO RETURNED SAMPLES WERE EXAMINED, THEN TESTED FOR FLOW USING WATER: BOTH SAMPLES WERE ABLE TO DRAW AND EXPEL WATER PROPERLY, AND NO LEAKAGE WAS OBSERVED DURING THE FLOW TEST. AS NO EVIDENCE OF MANUFACTURING DEFECTS WAS OBSERVED, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8162537. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT TWO SYRINGE 0.5ML 8MM 90 BX 450 MO HAVE BEEN FOUND DAMAGED AND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 2 INSULIN IS RUNNING DOWN FROM NEEDLE ONTO SKIN DURING THE INJECTION. VERBATIM: ISSUE: CONSUMER REPORTED INSULIN RUNNING DOWN FROM THE NEEDLE ON SKIN SIGHT DURING THE INJECTION. HE CLARIFIED AND STATED INSULIN CAME OUT DURING THE INJECTION. SAMPLE AVAILABLE-2. ITEM#328290. LOT#8162537 A. MANUFACTURED DATE-2018-07. EXPIRATION 2023-06-30. CONSUMER ALWAYS USES THE NEW SYRINGES FOR HIS INJECTION.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT TWO SYRINGE 0.5 ML 8 MM 90 BX 450 MO HAVE BEEN FOUND DAMAGED AND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 2 INSULIN IS RUNNING DOWN FROM NEEDLE ONTO SKIN DURING THE INJECTION. VERBATIM: ISSUE: CONSUMER REPORTED INSULIN RUNNING DOWN FROM THE NEEDLE ON SKIN SIGHT DURING THE INJECTION. HE CLARIFIED AND STATED INSULIN CAME OUT DURING THE INJECTION. SAMPLE AVAILABLE-2. ITEM#328290. LOT#8162537 A. MANUFACTURED DATE-2018-07. EXPIRATION 2023-06-30. CONSUMER ALWAYS USES THE NEW SYRINGES FOR HIS INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780426 SYRINGE 0.5ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8162537 00382903282906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other