BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11234034 · Received January 26, 2021

    Report

    Report Number
    1920898-2021-00113
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: 2/9/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (2) 3/10CC, 8MM RELION, BD MANUFACTURED SYRINGES ALONG WITH A SYRINGE AND A POLY BAG THAT IS NOT BD MANUFACTURED PRODUCT. CUSTOMER STATES THAT THE PLUNGER BENT, WAS VERY WEAK/THIN AND THAT THEY HAD DIFFICULTY DRAWING UP THE MEDICATION WITH THREE SYRINGES. THE RETURNED BD MANUFACTURED SYRINGES WERE TESTED AND BOTH WERE ABLE DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WERE DAMAGED AND UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER HAD DIFFICULTY DRAWING UP THE MEDICATION WITH THREE SYRINGES. ALSO, THE PLUNGER BENT AND WAS VERY WEAK/THIN. VERBATIM: RELION CONSUMER REPORTED DIFFICULTY DRAWING UP HIS MEDICATION WITH 3 SYRINGES. STATED THE PLUNGER ALSO SEEMS TO BEND AND IS VERY WEAK AND THIN ON THESE SYRINGES. STATED THIS PRODUCT IS A MESS AND HE WILL NOT BE USING THEM ANYMORE. REQUEST REFUND.LOT # 0160001. CAT # 328512. DATE OF EVENT: (B)(6) 2021 FOR ALL ISSUES REPORTED SAMPLES: YES, SENDING MAIL KIT."

    Additional Manufacturer Narrative · 1

    "MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 3 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WERE DAMAGED AND UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER HAD DIFFICULTY DRAWING UP THE MEDICATION WITH THREE SYRINGES. ALSO, THE PLUNGER BENT AND WAS VERY WEAK/THIN. VERBATIM: RELION CONSUMER REPORTED DIFFICULTY DRAWING UP HIS MEDICATION WITH 3 SYRINGES. STATED THE PLUNGER ALSO SEEMS TO BEND AND IS VERY WEAK AND THIN ON THESE SYRINGES. STATED THIS PRODUCT IS A MESS AND HE WILL NOT BE USING THEM ANYMORE. REQUEST REFUND. LOT #0160001, CAT # 328512 DATE OF EVENT: (B)(6) 2021 FOR ALL ISSUES REPORTED SAMPLES: YES, SENDING MAIL KIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129303 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1