BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 31G X 6MM 3B TW 50CT

    MDR report key: 11823952 · Received May 14, 2021

    Report

    Report Number
    3014704491-2021-00002
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    UDI-DI
    00681131386807
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. CLOG TEST AND THREAD FUNCTION WAS CONDUCTED ON 7PCS RETENTION SAMPLES. NO FAILURE WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PN RELION 31G X 6MM 3B NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION AND WAS DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320617; BATCH NO. 0140339. THE CONSUMER REPORTED NEEDLE CLOGGED DURING PRIMING AND STATED THAT THERE IS NO INSULIN FLOW. THE CONSUMER ALSO REPORTED THAT THE NEEDLES WILL NOT ATTACH PROPERLY ONTO THE PEN. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 PN RELION 31G X 6MM 3B NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION AND WAS DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :MATERIAL NO. 320617, BATCH NO. 0140339.THE CONSUMER REPORTED NEEDLE CLOGGED DURING PRIMING AND STATED THAT THERE IS NO INSULIN FLOW.THE CONSUMER ALSO REPORTED THAT THE NEEDLES WILL NOT ATTACH PROPERLY ONTO THE PEN. DATE OF EVENT: UNKNOWN.SAMPLES: DISCARDED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725817 PN RELION 31G X 6MM 3B TW 50CT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140339 00681131386807

    Patients

    Seq Age Sex Outcome Treatment
    1