BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE 31GX5MM 7 PACK

    MDR report key: 8465573 · Received March 29, 2019

    Report

    Report Number
    3006948883-2019-00226
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 11, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR OF LOT 8123354 WAS REVIEWED AND NO QN FOUND. INSPECTED 7PCS RETENTION PARTS ANGLE AND APPEARANCE, ALL RESULTS PASSED. 2 PCS SAMPLES WERE RECEIVED, ONE OF RETURNED SAMPLE(BROKEN IV END) WAS REVIEWED, WE FOUND DEFORMATION SHOWED ON THE INTERESTING SURFACE OF NEEDLE BROKEN POINT, IT WOULD BE CAUSED BY EXTERNAL EXCESSIVELY FORCE. ANOTHER SAMPLE(NO SHIELD, NO LABEL) IS IV BENT OBVIOUSLY, AND IT WAS REJECTED AS DEFECT PARTS UNDER IV END VISION INSPECTION SYSTEM. BASED ON INVESTIGATION ABOVE, THE COMPLAINT IS NOT MANUFACTURE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER REMOVING THE PEN NEEDLE 31GX5MM 7 PACK, THE NEEDLE BROKE OFF IN THE PATIENT'S BODY AND HAD TO BE SURGICALLY REMOVED THE FOLLOWING EVENING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON MARCH 13 AT AROUND 8 P.M,AFTER REMOVING THE PEN NEEDLE ,IT WAS FOUND THE NEEDLE BROKEN IN PATIENT'S BODY.THE BROKEN NEEDLE WAS REMOVED BY SURGERY ON THE EVENING OF MARCH 14."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 AFTER REMOVING THE PEN NEEDLE 31GX5MM 7 PACK, THE NEEDLE BROKE OFF IN THE PATIENT'S BODY AND HAD TO BE SURGICALLY REMOVED THE FOLLOWING EVENING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON MARCH 13 AT AROUND 8 P.M, AFTER REMOVING THE PEN NEEDLE ,IT WAS FOUND THE NEEDLE BROKEN IN PATIENT'S BODY. THE BROKEN NEEDLE WAS REMOVED BY SURGERY ON THE EVENING OF MARCH 14."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256347 PEN NEEDLE 31GX5MM 7 PACK HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 8123354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention