BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG

    MDR report key: 11346616 · Received February 18, 2021

    Report

    Report Number
    1920898-2021-00196
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 24, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048130
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/18/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1CC, 8MM SYRINGE. CUSTOMER STATES THAT THERE WAS FOREIGN MATTER ON THE NEEDLE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED TWO HARD, CLEAR DROPLETS OF MATERIAL ON THE CANNULA SHAFT. THE SAMPLE WAS EXAMINED UNDER UV LIGHT AND BOTH DROPLETS GLOWED UNDER UV LIGHT, INDICATING THAT THE MATERIAL ON THE CANNULA SHAFT IS MOST LIKELY ADHESIVE SPLATTER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0232158. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE NEEDLE. VERBATIM: FROM PHONE CALL ON 2021-01-25 17:04:22: CALLED PHARMACIST BACK TO SEE IF SHE WAS ABLE TO REACH THE CONSUMER. TECH STATED, PHARMACIST HAS GONE FOR THE DAY AND I CAN CALL BACK TOMORROW. CL WALGREENS PHARMACIST STATED, SHE NOTICED WHAT APPEARS TO BE "LIGHT BLUE, GLUE STUCK ON THE NEEDLE" SYRINGE WAS UNUSED STATED, A CONSUMER CALLED THE PHARMACY TO COMPLAIN OF THE SAME PROBLEM, SO THE PHARMACIST CHECKED ONE OF THE BOXES IN INVENTORY AND FOUND THE SAME ISSUE CONSUMER REPORTED. PHARMACIST STARTED TO GIVE ME THE CONSUMERS INFORMATION BUT I EXPLAINED, THE CONSUMER NEEDED TO CALL IN. 1 SYRINGE AFFECTED".

    Additional Manufacturer Narrative · 1

    "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 A SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE NEEDLE. VERBATIM: FROM PHONE CALL ON 2021-01-25 17:04:22: CALLED PHARMACIST BACK TO SEE IF SHE WAS ABLE TO REACH THE CONSUMER. TECH STATED, PHARMACIST HAS GONE FOR THE DAY AND I CAN CALL BACK TOMORROW. (B)(6) PHARMACIST STATED, SHE NOTICED WHAT APPEARS TO BE "LIGHT BLUE, GLUE STUCK ON THE NEEDLE". SYRINGE WAS UNUSED. STATED, A CONSUMER CALLED THE PHARMACY TO COMPLAIN OF THE SAME PROBLEM, SO THE PHARMACIST CHECKED ONE OF THE BOXES IN INVENTORY AND FOUND THE SAME ISSUE CONSUMER REPORTED. PHARMACIST STARTED TO GIVE ME THE CONSUMERS INFORMATION BUT I EXPLAINED, THE CONSUMER NEEDED TO CALL IN. 1 SYRINGE AFFECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239575 SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928856 UNKNOWN 00311917048130

    Patients

    Seq Age Sex Outcome Treatment
    1