BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERIC MEDICAL LLC

    MDR report key: 24870249 · Received April 14, 2026

    Report

    Report Number
    3003560965-2026-00010
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    JKA
    UDI-DI
    00850028131046
    PMA / PMN Number
    K172763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. REVIEW OF PRODUCTION PROCESS THE BATCH RECORDS RELATED TO THE PRODUCTION PROCESS AND FINISHED PRODUCT RELEASE INSPECTION RECORDS OF THIS BATCH WERE TRACED. NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION PROCESS AND FINISHED PRODUCT INSPECTION PROCESS. THE FINISHED PRODUCT PASSED ALL TESTS, AND NEITHER THE PRODUCTION PROCESS NOR RAW MATERIALS HAD BEEN CHANGED. 2. RETAINED SAMPLE TESTING: FIVE RETAINED SAMPLES OF THE SAFETY BLOOD COLLECTION SET WITH BATCH NO.: 250920 AND SPECIFICATION: 23G 3/4" / 1/2" WERE SELECTED FOR TESTING: VISUAL INSPECTION: THE NEEDLE TIP WAS SHARP, STRAIGHT AND FREE OF BENDING; ALL COMPONENTS WERE INTACT WITHOUT DAMAGE. FLOW TESTING WAS PERFORMED ON 2 SAMPLES, AND ALL RESULTS MET THE FINISHED PRODUCT REQUIREMENTS. PUNCTURE TESTS SIMULATING CLINICAL USE WERE PERFORMED ON 3 SAMPLES. ALL PUNCTURED NORMALLY, WITH NO PROTRUSION OF THE TUBING FROM THE SIDE OF THE NEEDLE TIP SHIELDING PROTECTIVE SHEATH. 3. ROOT CAUSE ANALYSIS 1) BASED ON THE ABOVE INVESTIGATION, THE ANALYSIS IS AS FOLLOWS: ACCORDING TO THE CUSTOMER FEEDBACK THAT "DURING BLOOD COLLECTION, THE TUBING PROTRUDED FROM THE SIDE OF THE NEEDLE TIP SHIELDING PROTECTIVE SHEATH, CAUSING THE SAFETY DEVICE TO FAIL TO ACTIVATE NORMALLY", OUR PRELIMINARY ANALYSIS INDICATES THAT THIS MAY BE CAUSED BY IMPROPER CLINICAL HANDLING (E.G., SINGLE-SIDED GRIPPING), LEADING TO THE TUBING SLIPPING OUT FROM THE SIDE OF THE SHEATH AND PREVENTING THE SAFETY DEVICE FROM SHIELDING PROPERLY. THIS SAFETY BLOOD COLLECTION SET IS EQUIPPED WITH A DOUBLE-WING NEEDLE HANDLE, WHICH REQUIRES BOTH WINGS TO BE HELD SIMULTANEOUSLY DURING PUNCTURE. IT IS RECOMMENDED THAT USERS STRICTLY OPERATE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. 2) A. REGARDING THE DIFFICULTY IN USING THE SAFETY BLOOD COLLECTION SET: IT IS RECOMMENDED THAT THE CUSTOMER FOLLOW THE INSTRUCTIONS FOR USE AND PROPERLY ACTIVATE THE SAFETY DEVICE. B. REGARDING POOR BLOOD FLASHBACK AND SLOW BLOOD FLOW: BASED ON THE CUSTOMER'S DESCRIPTION, SLOW BLOOD FLOW INDICATES THAT THE SAFETY BLOOD COLLECTION SET IS UNOBSTRUCTED AND NOT BLOCKED. THE BLOOD COLLECTION PRINCIPLE RELIES ON THE VACUUM NEGATIVE PRESSURE OF THE BLOOD COLLECTION TUBE AND HUMAN BLOOD PRESSURE TO DRAW BLOOD INTO THE TUBE. THEREFORE, THE ISSUE MAY BE RELATED TO FACTORS SUCH AS THE NEEDLE TIP ADHERING TO THE BLOOD VESSEL WALL OR PENETRATING THROUGH THE VESSEL, INSUFFICIENT OR NO VACUUM IN THE COLLECTION TUBE, OR HIGH BLOOD VISCOSITY. C. REGARDING DIFFICULTY IN ACTIVATING THE SAFETY DEVICE: THE SAFETY SHIELD OF THIS PRODUCT IS OF MECHANICAL STRUCTURE. DURING OPERATION, THE USER SHOULD PINCH THE LEFT AND RIGHT SIDES OF THE SAFETY DEVICE HOUSING AND PULL THE TUBING TO RETRACT THE NEEDLE INTO THE SAFETY SHIELD. THE ISSUE MAY HAVE OCCURRED BECAUSE THE OPERATOR PINCHED THE TOP AND BOTTOM SURFACES OF THE SAFETY SHIELD HOUSING DURING CLINICAL OPERATION, CAUSING THE HOUSING TO PRESS AGAINST THE HUB WINGS AND PREVENTING SMOOTH RETRACTION OF THE NEEDLE.

    Description of Event or Problem · 0

    COMPLAINT 1: PHLEBOTOMIST EXPERIENCED ISSUE THIS MORNING WHEN USING THE HOSPITAL'S NEW MAVERIC BUTTERFLY. THE TUBING PROTRUDED FROM THE SIDE OF THE SAFETY SLEEVE AND PREVENTED PROPER ACTIVATION OF THE SAFETY DEVICE. THE PHLEBOTOMIST STATES THIS IS THE SECOND TIME THIS HAS HAPPENED. SEE SAMPLE PHOTO BELOW OF REPORTED ISSUE: COMPLAINT 2: THE ASSOCIATES INCLUDING OUR LEAD PHLEBOTOMIST SHARED THAT THE NEW BUTTERFLY DEVICES ARE DIFFICULT TO USE. THEY ARE HARD TO MANEUVER. THEY DON'T SEE THE FLASH. EVEN THOUGH YOU'RE IN THE VEIN, THE BLOOD FLOW IS SLUGGISH. AS STATED, ENGAGING THE SAFETY IS DIFFICULT. THEY HAVE CONCERNS THAT A POTENTIAL SHARPS INJURY WILL LIKELY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940788 MAVERIC MEDICAL LLC SAFETY BLOOD COLLECTION SET JKA ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 23G*3/4" 12'' TUBING 250920 00850028131046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown