BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-100 INSULIN SYRINGE 1ML 31G X5/16" SYRINGE

    MDR report key: 19431301 · Received May 30, 2024

    Report

    Report Number
    1035907-2024-00023
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Report Date
    May 30, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OEM INVESTIGATION REPORT, (B)(4) WAS REVIEWED ON 29MAY2024. THE INVESTIGATION WAS INITIATED BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT ALONG WITH ACCOMPANYING PHOTOS. HOWEVER, THE PRODUCTS IN QUESTION WERE NOT SENT BY THE COMPLAINANT. THEREFORE, THE INVESTIGATION PROCEEDED USING THE OEM'S RETAINED (HOUSE) SAMPLES OF CAT.# 26012, LOT# 231103. ANALYSIS: VISUAL INSPECTION: 100 RETAINED (HOUSE) SAMPLES UNDERWENT VISUAL INSPECTION, REVEALING NO INSTANCES OF "BROKEN OR BENT NEEDLE" ACROSS ALL SAMPLES. VIAL PENETRATION TEST: 10 RETAINED (HOUSE) SAMPLES WERE SUBJECTED TO THE VIAL PENETRATION TEST USING A USB MICROSCOPE WITH X200 MAGNIFICATION. NO BENDING OR BREAKAGE OF THE NEEDLE TIP WAS OBSERVED IN ANY OF THE TESTED SAMPLES. NEEDLE PULL TEST: 30 RETAINED (HOUSE) SAMPLES UNDERWENT THE NEEDLE PULL TEST TO ASSESS THE STRENGTH OF THE BOND BETWEEN THE HUB AND THE NEEDLE. ALL SAMPLES MET THE TEST CRITERIA WITH NO INSTANCES OF NON-CONFORMITY. QUALITY RECORDS REVIEW: COMPREHENSIVE REVIEW OF QUALITY RECORDS INCLUDING INCOMING INSPECTION, STS TUBE, IN-PROCESS INSPECTION, AND ASSEMBLY DOCUMENTATION REVEALED NO ISSUES OR NON-CONFORMITIES. STIFFNESS AND RESISTANCE TO BREAKAGE TESTS WERE CONDUCTED PER ISO9626:2016 STANDARD AND PASSED SATISFACTORILY. COMMUNICATION WITH COMPLAINANT: DESPITE MULTIPLE ATTEMPTS VIA EMAIL TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT TO AID IN THE INVESTIGATION, NO RESPONSE WAS RECEIVED. CONCLUSION: BASED ON THE AVAILABLE DATA AND INVESTIGATION RESULTS, POTENTIAL CAUSES SUCH AS MISHANDLING, NEEDLE REUSE, INCORRECT CAP REMOVAL, AND DEFECTS IN THE PRODUCTION PROCESS ARE CONSIDERED. HOWEVER, DUE TO THE LACK OF ADDITIONAL INFORMATION AND INCONCLUSIVE EVIDENCE, THE ROOT CAUSE REMAINS UNKNOWN. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED HAVING ISSUES WITH SOME OF THE SKU# 26012 INSULIN SYRINGES. THE NEEDLES HAVE BROKEN OR BENT AT THE INJECTION SITE, AND SOME PHOTOS WERE PROVIDED TO FURTHER EXPLAIN THE PROBLEM. IT WAS NOTED IN THE EMAIL THAT SIMILAR ISSUES WERE OBSERVED BY 5 INJECTORS OF MODERN MEDICAL PRODUCTS ON SEVERAL OCCASIONS IN THEIR SANTA MONICA, LOS ANGELES AND NEWPORT BEACH LOCATIONS. THERE WERE NO REPORTED INJURIES OR PATIENT CONSEQUENCES AS A RESULT OF THESE INCIDENTS AS THEY WERE ABLE TO UTILIZE SIMILAR AVAILABLE SYRINGES IN THEIR OFFICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229864 U-100 INSULIN SYRINGE 1ML 31G X5/16" SYRINGE INSULIN SYRINGE FMF EXELINT INTERNATIONAL, CO. 231103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown