BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27GX1-1/2"

    MDR report key: 21721941 · Received March 28, 2025

    Report

    Report Number
    1035907-2025-00028
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 27, 2025
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221264265
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INCOMING INSPECTION HAS BEEN PERFORMED ON PRODUCT#: 26426, LOT: 231101 IN ACCORDANCE WITH SOP-11, INCOMING INSPECTION PROCEDURE. THE LOT PASSED THE INSPECTION WITH NO NON-CONFORMITIES REPORTED. THE CMO HAS CONDUCTED AN INVESTIGATION THAT INCLUDED THE FOLLOWING: PRODUCTION PROCESS REVIEW: THE PRODUCTION RECORDS OF THIS BATCH WERE REVIEWED, AND NO ABNORMALITIES WERE FOUND IN THE PRODUCTION PROCESS. THE RAW MATERIALS AND PRODUCTION TECHNIQUES REMAINED UNCHANGED. BATCH SAMPLE INSPECTION: TWENTY PIECES OF SAMPLES FROM BATCH NUMBER: 231101, SPECIFICATION 27G×1-1/2", WERE TESTED: 1) EACH SAMPLE WAS INSPECTED FOR APPEARANCE. ALL NEEDLE TUBES AND HUBS WERE FULLY BONDED WITH ADHESIVE, AND NO ABNORMALITIES WERE OBSERVED. 2) TEN SAMPLES WERE TESTED FOR RIGIDITY AND TOUGHNESS ACCORDING TO THE ISO 7864:2016 STANDARD. ALL SAMPLES PASSED THE TEST WITHOUT ANY FRACTURES OBSERVED. 3) THE REMAINING TEN SAMPLES WERE TESTED FOR FIRMNESS TEST IN ACCORDANCE TO ISO 7864:2016. A 22N PULLING FORCE WAS APPLIED, NO DETACHMENT OCCURRED BETWEEN HUBS AND NEEDLE TUBES, AND NO NEEDLE TUBE FRACTURES WERE DETECTED. ALL TEST PERFORMED PASSED THE INSPECTION AND WERE DEEMED QUALIFIED. THE COMPLAINANT STATED THAT THE DEFECTIVE NEEDLE HUB WAS IMMEDIATELY DISCARDED, AND THEREFORE WON'T BE AVAILABLE FOR INVESTIGATION. THE COMPLAINANT CONFIRMED ON (B)(6) 2025, THAT THE NEEDLE HAS BEEN RETRIEVED FROM THE PATIENT, AND WAS ADVISED TO PROVIDE PHOTOS, VIDEOS, AND MEASUREMENTS OF THE NEEDLE. IN SUMMARY, ALL RETAINED SAMPLES WERE FOUND TO BE QUALIFIED FOR PRODUCT RELEASE WITH NO NEEDLE DETACHMENT OR BREAKAGE DETECTED IN THE TESTED SAMPLES. IT IS LIKELY THAT THE NEEDLE COULD BREAK IF BEND BEYOND THE 20 DEGREES LIMIT OR SUBJECTED TO EXTERNAL FORCE DURING CLINICAL USE; HOWEVER, THIS CANNOT BE CONFIRMED. THEREFORE, THE ROOT CAUSE REMAINS UNCONFIRMED DUE TO THE LACK OF DEFECTIVE PRODUCT TO EXAMINE.

    Description of Event or Problem · 0

    THE CALLER REPORTED THAT DURING NECK SURGERY, THE HYPODERMIC NEEDLE SNAPPED DURING THE PROCEDURE. THE DOCTOR ATTEMPTED TO LOCATE THE NEEDLE DURING THE PROCEDURE BUT COULD NOT FIND IT. THREE DAYS LATER, THE PATIENT WAS ADVISED TO UNDERGO AN X-RAY. THE X-RAY RESULTS CONFIRMED THE NEEDLE HAD BEEN LEFT IN THE PATIENT'S NECK. THE DOCTOR STATED THAT THE PATIENT DID NOT FEEL OR EXPERIENCE ANY PAIN WHEN THE ISSUE WAS INITIALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749667 EXEL HYPO NDL 27GX1-1/2" HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 26426 231101 00020221264265

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention