BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31G 6MM S/C U-100 RELION

    MDR report key: 11720801 · Received April 23, 2021

    Report

    Report Number
    2243072-2021-01249
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00681131138345
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 1.0ML 31G 6MM S/C U-100 RELION WAS DIFFICULT TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE WILL NOT DRAW. VERBATIM: FROM PHONE CALL ON 2021-04-12 14:36:06: CALLED CONSUMER TO OBTAIN LOT #, HE PROVIDED LOT # 9182252. CONSUMER SAID HE RECEIVED THE MAIL KIT SO I ASKED HIM TO RETURN THE SAMPLES AS SOON AS POSSIBLE AND HE SAID HE WILL. FROM PHONE CALL ON 2021-04-07 17:26:06: CALLED CONSUMER TO OBTAIN LOT #, CONSUMER STATED THAT HE DID NOT HAVE THE LOT # BUT HE WILL CALL BACK AND LEAVE A VOICEMAIL IF WE ARE CLOSED. VOICEMAIL: CONSUMER LEFT VOICEMAIL REPORTING THAT THE NEEDLE WILL NOT DRAW."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. DEVICE MANUFACTURE DATE: UNKNOWN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 1.0ML 31G 6MM S/C U-100 RELION WAS DIFFICULT TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE WILL NOT DRAW. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 14:36:06: CALLED CONSUMER TO OBTAIN LOT #, HE PROVIDED LOT # 9182252. CONSUMER SAID HE RECEIVED THE MAIL KIT SO I ASKED HIM TO RETURN THE SAMPLES AS SOON AS POSSIBLE AND HE SAID HE WILL. FROM PHONE CALL ON (B)(6) 2021 17:26:06: CALLED CONSUMER TO OBTAIN LOT #, CONSUMER STATED THAT HE DID NOT HAVE THE LOT # BUT HE WILL CALL BACK AND LEAVE A VOICEMAIL IF WE ARE CLOSED. VOICEMAIL: CONSUMER LEFT VOICEMAIL REPORTING THAT THE NEEDLE WILL NOT DRAW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611621 SYRINGE 1.0ML 31G 6MM S/C U-100 RELION HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328519 UNKNOWN 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1