BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL HYPO NDL 27GX1-1/2

    MDR report key: 22162886 · Received June 7, 2025

    Report

    Report Number
    1035907-2025-00029
    Event Type
    Injury
    Date Received
    June 7, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 13, 2025
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221264265
    PMA / PMN Number
    K861153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AN INVESTIGATION ON PRODUCT # 26426, LOT # 231101 HAS BEEN PERFORMED AND THE RESULTS ARE AS FOLLOWS: PRODUCTION PROCESS REVIEW: THE PRODUCTION RECORDS WERE REVIEWED, AND NO ABNORMALITIES WERE FOUND IN THE PRODUCTION PROCESS. THE RAW MATERIALS AND PRODUCTION TECHNIQUES REMAINED UNCHANGED. RETAINED SAMPLES TESTING OR BATCH SAMPLE INSPECTION: A TOTAL OF TWENTY PIECES OF RETAINED SAMPLES WERE INSPECTED FOR APPEARANCE. ALL NEEDLE TUBES AND HUBS WERE FULLY BONDED WITH ADHESIVES, AND NO ABNORMALITIES WERE OBSERVED. TEN SAMPLES WERE TESTED FOR RIGIDITY AND TOUGHNESS ACCORDING TO THE ISO 7864:2016. STANDARD. ALL SAMPLES TESTED PASSED WITHOUT ANY FRACTURES OBSERVED. THE REMAINING TEN SAMPLES WERE SUBJECTED TO FIRMNESS TEST ACCORDING TO ISO 7864:2016. A 22N PULLING FORCE WAS APPLIED, NO DETACHMENT OCCURRED BETWEEN THE HUBS AND THE NEEDLE TUBES, AND NO NEEDLE FRACTURES WERE DETECTED. FURTHERMORE, AN ADDITIONAL ANALYSIS HAS BEEN PERFORMED ON THE INFORMATION AND PHOTO PROVIDED BY THE COMPLAINANT. THE REPORTED MEASUREMENT LENGTH OF THE NEEDLE WAS 3.8 CM, WHICH WAS BENT AT THE 2.9CM POSITION OR MARK, INDICATING SIGNIFICANT BENT OR DEFORMATION OF THE NEEDLE. THE INTENDED USE OF THE INJECTION NEEDLE IS FOR INJECTING AND EXTRACTING LIQUIDS FROM THE HUMAN BODY. DURING CLINICAL USE, ESPECIALLY IN HARD POSITIONS OR HARD TO ACCESS AREAS SUCH AS THE RETROPATELLAR JOINT SPACE, THERE IS A RISK OF NEEDLE BREAKAGE OR DAMAGE. IF THE NEEDLE TUBE BECOMES STUCK AND AN EXCESSIVE FORCE IS APPLIED, THE BENDING ANGLE MAY EXCEED 20 DEGREE LIMIT, INCREASING THE RISK OF BENDING OR BREAKING OF THE NEEDLE TUBE. DEFECTIVE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. BASED ON THE RESULT OF THE INVESTIGATION CONDUCTED, ALL RETAINED SAMPLES TESTED PASSED THE INSPECTIONS AND TEST REQUIREMENTS FOR PRODUCT RELEASE, WITH NO NON CONFORMANCES OR QUALITY DEFECTS DETECTED. A POTENTIAL ROOT CAUSE MAY BE EXCESSIVE BENDING OF THE NEEDLE, EXCEEDING THE 20 DEGREE DEFLECTION LIMIT IN HARD POSITION OR HARD ACCESS AREAS LIKE THE RETROPATELLAR JOINT SPACE DURING CLINICAL USE. HOWEVER, THIS CANNOT BE CONFIRMED DUE TO THE LIMITED INFORMATION AND THE ABSENCE OF DEFECTIVE DEVICE TO EXAMINE. THEREFORE, THE ROOT CAUSE REMAINS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4). - PRODUCTION RECORDS FOR PRODUCT # 26426, LOT # 231101 WERE REVIEWED, THERE WERE NO ABONORMALITIES FOUND IDENTIFIED DURING THE MANUFACTURING PROCESS. . - A TOTLA OF TWENTY RETAINED SAMPLES WERE RANDOMLY SELECTED FOR ANALYSIS AND TESTING. THESE SAMPLES WERE TESTED FOR VISUAL APPEARANCE INSPECTION, RIGIDITY, TOUGHNESS, AND FIRMNESS DETECTION. AL TESTED SAMPLES MET THE SPECIFIED TEST REQUIREMENTS, WITH NO DEFECTS OR QUALITY ISSUES OBSERVED. -AT THE TIME OF THIS REPORT, THE DEFECTIVE DEVICE HAS NOT BEEN RETURNED BY THE COMPLAINANT FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    A COMPLAINANT REPORTED NEEDLE QUALITY ISSUE; THE NEEDLE BROKE OFF BEHIND KNEECAP. A SCALPEL HAD TO BE USED TO OPEN THE PATIENTS KNEECAP TO REMOVE THE NEEDLE. PRIOR TO THE KNEE INJECTION PROCEDURE, THEY ASPIRATED 27 CC OF SEROUS FLUID. AT THE END OF THE ASPIRATION, THEY NOTICED THAT THE NEEDLE HAD DISLODGED DEEP IN THE RETROPATELLAR SPACE. SURGICAL RETRIEVAL OF THE BROKEN OFF NEEDLE WAS REQUIRED, AS THE ENTIRE METALLIC NEEDLE WAS IN THE DEEP RETROPATELLAR SPACE. THE COMPLAINANT STATED THAT THEY WERE ABLE TO RETRIEVE THE BROKEN OFF AND DISLODGED NEEDLE IN ITS ENTIRETY VIA A HEMOSTAT, WITH THE AID OF FLUOROSCOPY AND SURGICAL DISSECTION. THE NEEDLE MEASUREMENT L (3.8 CM WHICH WAS BENT AT 2.9 CM).

    Description of Event or Problem · 0

    A COMPLAINANT REPORTED NEEDLE QUALITY ISSUE; THE NEEDLE BROKE OFF BEHIND KNEECAP. A SCALPEL HAD TO BE USED TO OPEN THE PATIENTS KNEECAP TO REMOVE THE NEEDLE. PRIOR TO THE KNEE INJECTION PROCEDURE, THEY ASPIRATED 27 CC OF SEROUS FLUID. AT THE END OF THE ASPIRATION, THEY NOTICED THAT THE NEEDLE HAD DISLODGED DEEP IN THE RETROPATELLAR SPACE. SURGICAL RETRIEVAL OF THE BROKEN OFF NEEDLE WAS REQUIRED, AS THE ENTIRE METALLIC NEEDLE WAS IN THE DEEP RETROPATELLAR SPACE. THE COMPLAINANT STATED THAT THEY WERE ABLE TO RETRIEVE THE BROKEN OFF AND DISLODGED NEEDLE IN ITS ENTIRETY VIA A HEMOSTAT, WITH THE AID OF FLUOROSCOPY AND SURGICAL DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392803 EXEL HYPO NDL 27GX1-1/2 HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 231101 00020221264265

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention