BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PEN NEEDLES 4MM X 32 GAUGE

    MDR report key: 15959314 · Received December 12, 2022

    Report

    Report Number
    2243072-2022-02133
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 21, 2022
    Report Date
    March 2, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE RELION PEN NEEDLES 4MM X 32 GAUGE ARE TOO SHORT AND WILL NOT GO INTO SKIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE 4MM PEN NEEDLES ARE TOO SHORT AND WILL NOT GO INTO THE SKIN. D1: MEDICAL DEVICE BRAND NAME: RELION PEN NEEDLES 4MM X 32 GAUGE D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU D4: UDI #: (B)(4). D4: CATALOG #: 320618 D4: MEDICAL DEVICE LOT #: 1154033 D4: MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026 H4: DEVICE MANUFACTURE DATE: 29-OCT-2021 G2: MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU G.5. PMA / 510(K)#: K170386 D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 03-JAN-2023 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (10) 32GX4MM PEN NEEDLES FROM LOT# 1154033 (4 OPEN AND 6 UNOPENED). THE CUSTOMER REPORTED THAT THE PEN NEEDLES ARE TOO SHORT WILL NOT GO INTO THE SKIN, ARE LEAKING. THE RETURNED SAMPLES WERE EXAMINED, THEN TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE, AND CANNULA LENGTH. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿- 0.0095¿ AND SPECS FOR 4MM CANNULA LENGTH: 0.109¿-0.203¿): DATA: POINT (PE/NPE) OUTER DIAMETER (IN.) LUBE CANNULA LENGTH (IN.) SAMPLE 1 GOOD/GOOD 0.0093 GOOD .160 SAMPLE 2 GOOD/GOOD 0.0093 GOOD .166 SAMPLE 3 GOOD/GOOD 0.0093 GOOD .160 SAMPLE 4 GOOD/GOOD 0.0093 GOOD .160 SAMPLE 5 GOOD/GOOD 0.0093 GOOD .157 SAMPLE 6 GOOD/GOOD 0.0093 GOOD .155 SAMPLE 7 GOOD/GOOD 0.0093 GOOD .164 SAMPLE 8 GOOD/GOOD 0.0093 GOOD .160 SAMPLE 9 GOOD/GOOD 0.0093 GOOD .154 SAMPLE 10 GOOD/GOOD 0.0093 GOOD .161 NO EVIDENCE OF IMPROPER CANNULA LENGTH OR POINT INTEGRITY DEFECTS WERE OBSERVED. NEXT, ALL 10 SAMPLES WERE TESTED FOR FLOW USING A TEST PEN INJECTOR. IT WAS OBSERVED THAT ALL 10 PEN NEEDLES WERE ABLE TO EXPEL PROPERLY ¿ NO EVIDENCE OF LEAKAGE OR IMPROPER FLOW WAS OBSERVED. THE ALLEGED ISSUES COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED FOR INVESTIGATION. DHR WAS REVIEWED AND THERE WERE NOT ANY QNS OR OTHER EVENTS THAT COULD BE RELATED TO THIS COMPLAINT. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION PEN NEEDLES 4MM X 32 GAUGE EXPERIENCED LEAKED FROM THE JUNCTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER ALSO REPORTED INSULIN LEAKING FROM THE INJECTION SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD PEN NEEDLE EXPERIENCED LEAKED FROM THE JUNCTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER ALSO REPORTED INSULIN LEAKING FROM THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181641 RELION PEN NEEDLES 4MM X 32 GAUGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1154033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown