BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 31G X 6MM 3B TW

    MDR report key: 11872359 · Received May 24, 2021

    Report

    Report Number
    3014704491-2021-00007
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    UDI-DI
    80382903206175
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. TESTED 7PCS RETENTION SAMPLES. NO FAILURE WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PN RELION 31G X 6MM 3B TW EXPERIENCED DIFFICULT OPERATION OR WAS NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320617; BATCH NO: 0140337. CONSUMER REPORTED THAT THE PEN NEEDLES WILL NOT ATTACH TO THE PEN. CONSUMER STATED THAT HE ATTACHES THE NEEDLE BY SNAPPING THEM ON TO THE PEN, HE SAID THAT IS THE WAY THAT HE DID IT IN THE PAST. I ADVISED CONSUMER THAT THE NEEDLES MUST BE TWISTED ON TO SECURELY ATTACH RATHER THAN SNAPPING THEM ON. HE TRIED ATTACHING THE NEEDLE WHILE ON THE PHONE AND IT WORKED. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, 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 THE PN RELION 31G X 6MM 3B TW EXPERIENCED DIFFICULT OPERATION OR WAS NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320617, BATCH NO: 0140337. CONSUMER REPORTED THAT THE PEN NEEDLES WILL NOT ATTACH TO THE PEN. CONSUMER STATED THAT HE ATTACHES THE NEEDLE BY SNAPPING THEM ON TO THE PEN, HE SAID THAT IS THE WAY THAT HE DID IT IN THE PAST. I ADVISED CONSUMER THAT THE NEEDLES MUST BE TWISTED ON TO SECURELY ATTACH RATHER THAN SNAPPING THEM ON. HE TRIED ATTACHING THE NEEDLE WHILE ON THE PHONE AND IT WORKED. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766417 PN RELION 31G X 6MM 3B TW PEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140337 80382903206175

    Patients

    Seq Age Sex Outcome Treatment
    1