BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11607178 · Received April 2, 2021

    Report

    Report Number
    3006948883-2021-00354
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 8, 2021
    Report Date
    May 7, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    UDI-DI
    80382903206175
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. TESTED 7PCS RETENTION SAMPLES OF THREAD FUNCTION, ALL RESULTS PASSED. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PN RELION 31G X 6MM 3B TW 50CT WOULD NOT ATTACH TO THE PEN AND WAS DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLE WILL NOT ATTACH TO THE KWIK PEN AND THE WHOLE NEEDLE ASSEMBLY DETACHED WHEN THE PEN NEEDLE WAS REMOVED. VERBATIM: CONSUMER REPORTED WILL NOT ATTACH ONTO THE KWIK PEN. SON ATTACHED ONTO THE PEN BUT WHEN REMOVES FROM THE PEN THE WHOLE NEEDLE ASSEMBLY GOES WITH IT. HE HAS BEEN USING THE PRIOR RELION PEN NEEDLES FOR APROX 6 MONTHSCONSUMERS DAD REPORTED THE MEASUREMENT ON NEW RELION BOX SAYS 6MM, 15/64,".25MM THAT IS .0001" DIFFERENT THAN HIS OLDER RELION PEN NEEDLE THAT WAS 6MM AND 1/4" . LOT # 0140337 CATALOG# 320617 DATE OF EVENT (B)(6) 2021 SAMPLE STATUS AWAITING SAMPLE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PN RELION 31G X 6MM 3B TW 50CT WOULD NOT ATTACH TO THE PEN AND WAS DIFFICULT TO OPERATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLE WILL NOT ATTACH TO THE KWIK PEN AND THE WHOLE NEEDLE ASSEMBLY DETACHED WHEN THE PEN NEEDLE WAS REMOVED. VERBATIM: CONSUMER REPORTED WILL NOT ATTACH ONTO THE KWIK PEN. SON ATTACHED ONTO THE PEN BUT WHEN REMOVES FROM THE PEN THE WHOLE NEEDLE ASSEMBLY GOES WITH IT. HE HAS BEEN USING THE PRIOR RELION PEN NEEDLES FOR APROX 6 MONTHS. CONSUMERS DAD REPORTED THE MEASUREMENT ON NEW RELION BOX SAYS 6MM, 15/64" , .25MM THAT IS .0001" DIFFERENT THAN HIS OLDER RELION PEN NEEDLE THAT WAS 6MM AND 1/4" . LOT # 0140337 CATALOG#: 320617, DATE OF EVENT; (B)(6) 2021. SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507568 PN RELION 31G X 6MM 3B TW 50CT HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 0140337 80382903206175

    Patients

    Seq Age Sex Outcome Treatment
    1