BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11072180 · Received December 24, 2020

    Report

    Report Number
    1920898-2020-01760
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    November 28, 2020
    Report Date
    February 11, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. 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 # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200894508] NOTED FOR OUT OF SPEC SHIELD PULL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM SYRINGE. VERBATIM: FROM PHONE CALL ON 2020-11-30 15:02:17: CONSUMER STATED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. STATED, SHIELDS WERE NOT DIFFICULT TO REMOVE. DISCARDED SAMPLES. SENDING REPLACEMENT BOX TO PHARMACY FOR PICK UP. INFORMATION FROM EMAIL BELOW: SENT: SATURDAY, NOVEMBER 28, 2020 10:08 AM "I ORDER SYRINGES FROM OPTUMRX MAIL ORDER. IN THE LAST 5 BOXES 1/3 OF THE TIME I PULL OFF THE ORANGE CAP TO THE SYRINGE, THE NEEDLE COMES OFF IN THE CAP. I'M THEN LEFT PUTTING THE CAP ON AND OFF IN THE HOPES THE NEEDLE WILL GO BACK INTO PLACE OR OTHER TIMES, I CAN'T AND THE SYRINGE IS UNUSABLE. I'M PREGNANT AND TAKE 10 SHOTS A DAY. I SHOULDN'T BE AVERAGING 3 SYRINGES A DAY THAT ARE FAULTY LIKE THIS. I'VE SINCE THROWN OUT THE OTHER BOXES, BUT HERE IS THE INFORMATION FROM THE LAST SYRINGE THIS HAPPENED TO:" BD ULTRA FINE INSULIN SYRINGE 3/10ML, 8MM, 31G, LOT 0090638 B.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0090638. MEDICAL DEVICE LOT #: 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 AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM SYRINGE. VERBATIM: FROM PHONE CALL ON 2020-11-30 15:02:17: CONSUMER STATED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. STATED, SHIELDS WERE NOT DIFFICULT TO REMOVE. DISCARDED SAMPLES. SENDING REPLACEMENT BOX TO PHARMACY FOR PICK UP. INFORMATION FROM EMAIL BELOW: SENT: SATURDAY, NOVEMBER 28, 2020 10:08 AM. "I ORDER SYRINGES FROM OPTUMRX MAIL ORDER. IN THE LAST 5 BOXES 1/3 OF THE TIME I PULL OFF THE ORANGE CAP TO THE SYRINGE, THE NEEDLE COMES OFF IN THE CAP. I'M THEN LEFT PUTTING THE CAP ON AND OFF IN THE HOPES THE NEEDLE WILL GO BACK INTO PLACE OR OTHER TIMES, I CAN'T AND THE SYRINGE IS UNUSABLE. I'M PREGNANT AND TAKE 10 SHOTS A DAY. I SHOULDN'T BE AVERAGING 3 SYRINGES A DAY THAT ARE FAULTY LIKE THIS. I'VE SINCE THROWN OUT THE OTHER BOXES, BUT HERE IS THE INFORMATION FROM THE LAST SYRINGE THIS HAPPENED TO:" BD ULTRA FINE INSULIN SYRINGE, 3/10ML, 8MM, 31G, LOT 0090638 B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536706 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0090638 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1