BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 24740492 · Received March 31, 2026

    Report

    Report Number
    3003560965-2026-00007
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 20, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    00304040003084
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1.PRODUCTION PROCESS REVIEW: IT WAS VERIFIED THAT THE RAW MATERIALS AND PRODUCTION PROCESS OF THIS BATCH OF HYPODERMIC NEEDLES HAD NOT BEEN CHANGED, NO ABNORMALITIES OCCURRED DURING THE PRODUCTION PROCESS, AND THE FINISHED PRODUCTS PASSED THE EX-FACTORY INSPECTION. 2.RETAINED SAMPLE INSPECTION: 100 RETAINED SAMPLES OF HYPODERMIC NEEDLES WITH BATCH NO.: 20250601 AND SPECIFICATION: 30G*1/2" WERE RANDOMLY SELECTED FOR INSPECTION. NO NEEDLE-PENETRATING-PROTECTIVE CAP PHENOMENON WAS FOUND IN ANY SAMPLE. 3.ROOT CAUSE ANALYSIS:DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER, IT CANNOT BE DETERMINED WHETHER THE NEEDLE PENETRATED THE PROTECTIVE CAP BEFORE USE OR DURING RE-SHEATHING AFTER DRUG PREPARATION. OUR PRELIMINARY ANALYSIS OF POSSIBLE CAUSES IS AS FOLLOWS: IF THE NEEDLE PENETRATING THE PROTECTIVE CAP WAS FOUND UPON OPENING THE PACKAGE, IT MAY BE CAUSED BY AN INDIVIDUAL PROTECTIVE CAP NOT VERTICALLY COMING DOWN FROM THE CHUTE AND BEING CAUGHT BY THE NEEDLE TIP, RESULTING IN THE NEEDLE TIP PENETRATING THE PROTECTIVE CAP DURING THE PROTECTIVE CAP CRIMPING PROCESS. DURING THE BLISTER PACKAGING PROCESS, THE FULL-INSPECTION OPERATOR FAILED TO DETECT AND REJECT THE DEFECTIVE PRODUCT IN TIME DUE TO THE INSPECTION ENVIRONMENT AND OTHER CONDITIONS, LEADING TO ITS OUTFLOW. IF THE PROBLEM WAS FOUND AFTER USE, IT MAY BE CAUSED BY IMPROPER OPERATION DURING RE-SHEATHING AFTER CLINICAL DRUG PREPARATION. AFTER USE, THE NEEDLE SHOULD BE DIRECTLY DISPOSED OF IN A SHARPS CONTAINER. RE-SHEATHING THE HYPODERMIC NEEDLE CARRIES THE RISK OF NEEDLE PENETRATION THROUGH THE PROTECTIVE CAP, AND SUCH OPERATION (RE-SHEATHING) DOES NOT COMPLY WITH THE REQUIREMENTS FOR DISPOSAL OF USED MEDICAL DEVICES.

    Additional Manufacturer Narrative · 0

    1.PRODUCTION PROCESS REVIEW: IT WAS VERIFIED THAT THE RAW MATERIALS AND PRODUCTION PROCESS OF THIS BATCH OF HYPODERMIC NEEDLES HAD NOT BEEN CHANGED, NO ABNORMALITIES OCCURRED DURING THE PRODUCTION PROCESS, AND THE FINISHED PRODUCTS PASSED THE EX-FACTORY INSPECTION. 2.RETAINED SAMPLE INSPECTION: 100 RETAINED SAMPLES OF HYPODERMIC NEEDLES WITH BATCH NO.: 20250601 AND SPECIFICATION: 30G*1/2" WERE RANDOMLY SELECTED FOR INSPECTION. NO NEEDLE-PENETRATING-PROTECTIVE CAP PHENOMENON WAS FOUND IN ANY SAMPLE. 3.ROOT CAUSE ANALYSIS:DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER, IT CANNOT BE DETERMINED WHETHER THE NEEDLE PENETRATED THE PROTECTIVE CAP BEFORE USE OR DURING RE-SHEATHING AFTER DRUG PREPARATION. OUR PRELIMINARY ANALYSIS OF POSSIBLE CAUSES IS AS FOLLOWS: IF THE NEEDLE PENETRATING THE PROTECTIVE CAP WAS FOUND UPON OPENING THE PACKAGE, IT MAY BE CAUSED BY AN INDIVIDUAL PROTECTIVE CAP NOT VERTICALLY COMING DOWN FROM THE CHUTE AND BEING CAUGHT BY THE NEEDLE TIP, RESULTING IN THE NEEDLE TIP PENETRATING THE PROTECTIVE CAP DURING THE PROTECTIVE CAP CRIMPING PROCESS. DURING THE BLISTER PACKAGING PROCESS, THE FULL-INSPECTION OPERATOR FAILED TO DETECT AND REJECT THE DEFECTIVE PRODUCT IN TIME DUE TO THE INSPECTION ENVIRONMENT AND OTHER CONDITIONS, LEADING TO ITS OUTFLOW. IF THE PROBLEM WAS FOUND AFTER USE, IT MAY BE CAUSED BY IMPROPER OPERATION DURING RE-SHEATHING AFTER CLINICAL DRUG PREPARATION. AFTER USE, THE NEEDLE SHOULD BE DIRECTLY DISPOSED OF IN A SHARPS CONTAINER. RE-SHEATHING THE HYPODERMIC NEEDLE CARRIES THE RISK OF NEEDLE PENETRATION THROUGH THE PROTECTIVE CAP, AND SUCH OPERATION (RE-SHEATHING) DOES NOT COMPLY WITH THE REQUIREMENTS FOR DISPOSAL OF USED MEDICAL DEVICES.

    Description of Event or Problem · 0

    THE CUSTOMER IS GETTING POKED THROUGH THE CAP. LEFT A VOICE MESSAGE FOR IVRIL, THE NURSE TO ANSWER ADDITIONAL QUESTIONS ABOUT THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER IS GETTING POKED THROUGH THE CAP. LEFT A VOICE MESSAGE FOR IVRIL, THE NURSE TO ANSWER ADDITIONAL QUESTIONS ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478977 HENRY SCHEIN INC HYPODERMIC NEEDLES FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 30G*1/2'' 20250601 00304040003084

    Patients

    Seq Age Sex Outcome Treatment
    1