BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE HYPODERMIC NEEDLES FOR SINGLE USE

    MDR report key: 21783410 · Received April 7, 2025

    Report

    Report Number
    3004496829-2025-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Report Date
    April 3, 2025
    Manufacturer
    BERPU MEDICAL TECHNOLOGY CO. LTD
    Product Code
    FMI
    PMA / PMN Number
    K180417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE HUNDRED RETAINED PRODUCTS OF THE LOT NUMBER: 240425 WERE TESTED THROUGH STYLET INSPECTION. THE NEEDLE HOLES ARE UNBLOCKED. TAKE 10 SAMPLLES TO SIMULATE DRAWING AND INJECTION. NEEDLE PATENCY WAS CONFIRMED WITHOUT BLOCKAGE. THEN WE CHECK PRODUCTION BATCH RECORDS OF LOT NUMBER: 240425. THERE IS NO BLOCKAGE DURING MANUFACTURING. PROCESS, MATERIALS, EQUIPMENT HAVE NOT CHANGED. FINISHED PRODUCT ASSEMBLY EQUIPMENT HAS AN ON-LINE BLOCKING INSPECTION FUNCTION, WHICH CARRIES OUT FULL INSPECTION ON-LINE, AND THE INSPECTOR CONFIRMS THE INSPECTION FUNCTION OF THE EQUIPMENT 2 TIMES PER SHIFT. PROCESS AND FINISHED PRODUCT INSPECTION OF THE SAMPLING ARE QUALIFIED. WE ALSO CHECKED CUSTOMER COMPLAINTS OVER THE YEARS AND DID NOT FIND SIMILAR FEEDBACK. COMBINED WITH ANALYSIS OF PRODUCT USE, IF THE NEEDLE HOLE IS BLOCKED, IT IS UNABLE TO DRAW THE DRUG. THE USER SAID AT THE END OF THE INJECTION, THE NEEDLE WILL STOP DELIVERING DRUGS. WE THINK THAT THE NEEDLE HOLE IS UNBLOCKED WHILE DRAWING THE DRUG, BUT IT IS BLOCKED AT THE END OF THE INJECTION. WE SPECULATE THAT THE WITHDRAWN DRUGS CONTAIN POWDER. IF THE DRUG IS NOT FULLY DISSOLVED, THE POWDER PARTICLES MAY BLOCK THE NEEDLE HOLE.

    Description of Event or Problem · 0

    STERILE HYPODERMIC NEEDLES FOR SINGLE USE WITH SPECIFICATION 22GX1.5" AND LOT NO: 240425, RECEIVED FEEDBACK FROM A CUSTOMER: THERE ARE SERIOUS PROBLEMS OF THESE NEEDLES FROM TIME TO TIME. WE HAVE TRIED SEVERAL METHODS TO SOLVE THE PROBLEM, BUT THE PROBLEM PERSISTS. THESE NEEDLES ARE CLOGGED. THEY WOULD STOP DELIVERING THE MEDICATION AT THE END OF THE INJECTION, CAUSING THE HEALTHCARE PROVIDER TO NOT BE ABLE TO COMPLETE THE ENTIRE INJECTION AND HAVE TO INSERT THE NEEDLE AGAIN. CUSTOMER (IMPORTER) TOLD US THAT THEY RECEIVED A COMPLAINT FOR 1 BOX OF SAMPLE: (B)(6), LOT #: 240425. THE SAMPLE WAS RECEIVED, BUT THEY ARE UNABLE TO CONFIRM THE COMPLAINT. ALL SAMPLES HAVE BEEN USED AND ARE NOT RETURNABLE. WE HAVE CONTACTED THE CUSTOMER (IMPORTER) AND HOPE THAT THE CUSTOMER CAN CONTACT THE REPORTER FOR SPECIFIC INFORMATION ABOUT THE INCIDENT. THE CUSTOMER HAS INFORMED US THE REPORT NUMBER OF THE MDR: 1417592-2025-00002 BUT HAS NOT PROVIDED SPECIFIC INFORMATION ABOUT THE REPORT. THE REPORTER HAS NOT BEEN CONTACTED. WE ALSO TRIED TO SEARCH FOR THE REPORT AT HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFMAUDE/RESULTS.CFM AND DID NOT FIND RELEVANT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569914 STERILE HYPODERMIC NEEDLES FOR SINGLE USE STERILE HYPODERMIC NEEDLES FOR SINGLE USE FMI BERPU MEDICAL TECHNOLOGY CO. LTD 22GX1.5" 240425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown