BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ HUBER 19G X 25MM

    MDR report key: 11605452 · Received April 1, 2021

    Report

    Report Number
    3006260740-2021-01081
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 2, 2021
    Report Date
    May 17, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741089077
    PMA / PMN Number
    K071846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DAMAGED LUER ADAPTER WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS TWO 19GA X 1¿ EZ HUBER SAFETY INFUSION SETS. THE FIRST SAMPLE (SAMPLE 1) EXHIBITED USE RESIDUES THROUGHOUT. THE SAFETY WAS ENGAGED AND A CAP WAS ATTACHED TO THE LUER ADAPTER. THE SECOND SAMPLE (SAMPLE 2) WAS RECEIVED IN ITS ORIGINAL SEALED PACKAGING. ATTEMPTS TO INFUSE WATER THROUGH BOTH SAMPLES USING A 12ML SYRINGE REVEALED BOTH TO BE PATENT TO INFUSION AND ASPIRATION WITH NO OBSERVED LEAKS. NO LEAKS WERE OBSERVED DURING SUSTAINED (>15 SECONDS) HYDRAULIC PRESSURIZATION. MICROSCOPIC INSPECTION OF SAMPLE 1 REVEALED SUPERFICIAL STRESS FRACTURES THROUGHOUT THE LUER ADAPTER. MICROSCOPIC INSPECTION OF SAMPLE 2 WAS UNREMARKABLE. BOTH LUER ADAPTERS WERE INSPECTED USING AN ISO TAPER GAUGE AND SAMPLE 1 EXHIBITED AN OUT OF SPEC LUER. SAMPLE 2 WAS UNREMARKABLE. WHILE NO LEAKS WERE IDENTIFIED, THE TOO LARGE LUER ORIFICE EXHIBITED BY SAMPLE 1 SUGGESTED THAT LEAKING MAY HAVE OCCURRED DURING USE WITH OTHER ACCESSORIES. THE STRESS FRACTURING SUGGESTED THAT FORCEFUL INSERTION OF A TAPERED OBJECT, SUCH AS A SLIP-FIT LUER ACCESSORY LIKELY CAUSED/CONTRIBUTED TO THE LUER DAMAGE. SAMPLE 2 WAS UNUSED, UNDAMAGED AND APPEARED TO HAVE BEEN RETURNED AS AN UNUSED LOT SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED LEAK WAS NOTED AT THE LUER LOCK CONNECTION POINT. THE USERS ALSO FOUND THAT IF A 3-WAY VALVE IS INSTALLED BETWEEN THE CANNULA AND THE INFUSION LINE, THERE IS NO LONGER ANY LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REER1219 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED LEAK WAS NOTED AT THE LUER LOCK CONNECTION POINT. THE USERS ALSO FOUND THAT IF A 3-WAY VALVE IS INSTALLED BETWEEN THE CANNULA AND THE INFUSION LINE, THERE IS NO LONGER ANY LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503131 EZ HUBER 19G X 25MM SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 SHG19-100 REER1219 00801741089077

    Patients

    Seq Age Sex Outcome Treatment
    1 Other