BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 31G X 6MM 3B TW

    MDR report key: 11740985 · Received April 28, 2021

    Report

    Report Number
    3006948883-2021-00456
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 31, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    UDI-DI
    80382903206175
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. TESTED 7PCS RETENTION SAMPLES OF THREAD FUNCTION AND THE APPEARANCE OF THE BOX, ALL RESULTS PASSED. NO FAILURE WAS FOUND. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE PN RELION 31G X 6MM 3B TW EXPERIENCED AN INNER SHIELD/OUTER COVER/CAP THAT WOULD NOT ATTACH/DETACH, AND DIFFICULT OPERATION OR BEING UNABLE TO WORK/FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320617 BATCH NO: 0140337. CONSUMER REPORTED, SHE IS HAVING A HARD TIME ATTACHING NON PATIENT END TO INSULIN PENSTATED, PEN NEEDLES WILL NOT STAY ON. STATED, SHE NEVER HAD A PROBLEM IN THE PAST WITH THE OLD DESIGN, (CONSUMER NOTICE COLOR OF BOX CHANGED). DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 THREE PN RELION 31G X 6MM 3B TW EXPERIENCED AN INNER SHIELD/OUTER COVER/CAP THAT WOULD NOT ATTACH/DETACH, AND DIFFICULT OPERATION OR BEING UNABLE TO WORK/FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320617. BATCH NO: 0140337. CONSUMER REPORTED, SHE IS HAVING A HARD TIME ATTACHING NON PATIENT END TO INSULIN PENSTATED, PEN NEEDLES WILL NOT STAY ON. STATED, SHE NEVER HAD A PROBLEM IN THE PAST WITH THE OLD DESIGN, (CONSUMER NOTICE COLOR OF BOX CHANGED). DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636051 PN RELION 31G X 6MM 3B TW PEN NEEDLE FMI BD (SUZHOU) 0140337 80382903206175

    Patients

    Seq Age Sex Outcome Treatment
    1