BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 1/2IN

    MDR report key: 21354986 · Received February 11, 2025

    Report

    Report Number
    3002682307-2025-00016
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 24, 2025
    Report Date
    March 3, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 240108. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES A CANNULA COMPONENT WAS OBSERVED CROSSING THROUGH THE BLISTER PACKAGING. WE UNDERSTAND THAT THE CANNULA COMPONENT WAS CROSSING THROUGH THE SHIELD AS WELL. IT HAS BEEN DETERMINED THAT THIS DEFECT COULD BE PRODUCED IN THE LAST STEP OF THE ASSEMBLY MACHINE, WHEN THE SHIELD IS INTRODUCED TO THE NEEDLE. DUE TO SOME INSUFFICIENT ADJUSTMENT IN THE ASSEMBLY MACHINE, THE SHIELD WAS INCORRECTLY POSITIONED, BENDING THE CANNULA. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 30GA 1/2IN NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM GERMAN TO ENGLISH: HELLO, I AM A HOME DIALYSIS PATIENT AND I USE YOUR PRODUCTS, MAINLY SYRINGES, CANNULAS AND DEVICES FOR SAFE MEDICATION ADMINISTRATION VIA THE VEIN OR SUBCUTANEOUSLY! I HAD CANNULAS FROM YOU WITH THE SPECIAL YELLOW HUB, SIZE 0.3 × 13 MM. I TOOK THE CANNULAS OUT OF THE PACKAGING AND FELT AN EXTREME PAIN ON MY FINGER UNDER THE NAIL! WHEN I SAW EXACTLY WHAT HAD HAPPENED, I REALIZED THAT YOU HAD APPARENTLY MADE A MISTAKE WITH THE CANNULAS AND THAT A RIEGEL WHELDON CANNULA IS NO LONGER STERILE BECAUSE THE CANNULA HAD SOMEHOW PENETRATED THE CANNULA PROTECTION AND THE STERILE PACKAGING, SO THE NEEDLE WENT UNDER MY FINGERNAIL AND SINCE I WAS FULLY HEPARINIZED TO ENABLE DIALYSIS, I BLED CONTINUOUSLY FOR THREE AND A HALF HOURS! IT ALSO REALLY HURT! ACTUALLY, I'M USED TO HIGH QUALITY AND PLACE A GREAT DEAL OF VALUE ON IT. ACTUALLY, SOMETHING LIKE THIS SHOULDN'T HAPPEN. I'M ALSO IMMUNOCOMPROMISED. I HAVE ATTACHED A PICTURE FOR YOU! IN THE PICTURE, YOU CAN CLEARLY SEE THAT IT IS A PRODUCTION DEFECT BECAUSE THE PRODUCT IS STILL COMPLETELY SHRINK-WRAPPED! WHAT SHOULD I DO? SHOULD I DISCARD THE ENTIRE LOT BECAUSE AS SOON AS THE STERILE PACKAGING, WHICH SERVES AS A BARRIER, IS NO LONGER COMPLETELY INTACT, I CANNOT TREAT THE DEVICE AS STERILE EITHER! DO YOU WANT ME TO MAKE A COMPLAINT ABOUT THE PRODUCTS? I HAVE ATTACHED A PICTURE TO SHOW YOU THE PRODUCTION ERROR MARKED IN THE RED CIRCLE AND THE BACK WITH THE BATCH NUMBER!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657733 BD NEEDLE 30GA 1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON, S.A. 240108 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown