BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 31G X 6MM 3B TW

    MDR report key: 12089730 · Received June 29, 2021

    Report

    Report Number
    3014704491-2021-00031
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 22, 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
    NY, 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: 2021-07-13. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (72) 31GX6MM PEN NEEDLES FROM LOT# 0140337 (67 OPENED, 5 SEALED) AND 5 PEN INJECTORS (NON-BD PRODUCT). THE CUSTOMER REPORTED THAT THE NEEDLE IS DIFFICULT TO REMOVE FROM THE PEN AFTER THE INJECTION. ALL 72 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT NONE EXHIBITED DAMAGE TO THE NON-PATIENT END (NPE) CANNULA. 30 OUT OF THE 72 RETURNED PEN NEEDLES WERE TESTED FOR ATTACHMENT/DETACHMENT USING A TEST PEN INJECTOR. ALL 30 TESTED SAMPLES WERE ABLE TO ATTACH TO/DETACH FROM THE TEST PEN INJECTOR PROPERLY. NO DEFECT WAS OBSERVED. DHR WAS REVIEWED FOR LOT# 0140337 AND NO QN FOUND. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PN RELION 31G X 6MM 3B TW COVER WAS NOT ABLE TO ATTACH AS INTENDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE IS DIFFICULT TO REMOVE FROM THE PEN AFTER THE INJECTION.   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. INVESTIGATION SUMMARY : EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. CAPA/SA - BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD PN RELION 31G X 6MM 3B TW COVER WAS NOT ABLE TO ATTACH AS INTENDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE IS DIFFICULT TO REMOVE FROM THE PEN AFTER THE INJECTION.   DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985758 PN RELION 31G X 6MM 3B TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140337 00681131386807

    Patients

    Seq Age Sex Outcome Treatment
    1