BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 32G X 4MM

    MDR report key: 12364509 · Received August 25, 2021

    Report

    Report Number
    3014704491-2021-00098
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 27, 2021
    Report Date
    August 31, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-10. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) SEALED 32GX 4MM BD PEN NEEDLES (1 FROM LOT# 0136696, 1 FROM LOT# 0140356, AND 1 FROM LOT# 0217116). THE CONSUMER REPORTED THAT IT TAKES LONGER TO PRESS DOWN THE DOSAGE BUTTON DURING INJECTION. ALL 3 RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR. ALL 3 PEN NEEDLES WERE ABLE TO EXPEL PROPERLY. NO DEFECTS WERE OBSERVED. DHR WAS REVIEWED FOR LOT# 0140356 AND NO QN FOUND. DHR WAS REVIEWED FOR LOT# 0136696 AND NO QN FOUND. DHR WAS REVIEWED FOR LOT#0217116 AND NO QN FOUND. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PN RELION 32G X 4MM WERE DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT EVEN AFTER COMPLETING THE FLOW CHECK THE INJECTION TAKES LONGER TO PRESS DOWN THE DOSE BUTTON. DATE OF EVENT: UNKNOWN. SAMPLE STATUS: AWAITING SAMPLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 0217116 ¿ DEVICE EXPIRATION DATE : 08/31/2025 ¿ DEVICE MANUFACTURE DATE : 02/01/2021, LOT # : 0136696 ¿ DEVICE EXPIRATION DATE : 05/31/2025 ¿ DEVICE MANUFACTURE DATE : 08/31/2020, LOT # : 0140356 ¿ DEVICE EXPIRATION DATE : 05/31/2025 ¿ DEVICE MANUFACTURE DATE : 11/03/2020. 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 2 BD PN RELION 32G X 4MM WERE DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT EVEN AFTER COMPLETING THE FLOW CHECK THE INJECTION TAKES LONGER TO PRESS DOWN THE DOSE BUTTON. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264313 PN RELION 32G X 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1