BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 7/8IN BSG CLEAR HUB

    MDR report key: 23200703 · Received October 2, 2025

    Report

    Report Number
    1911916-2025-00666
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 2, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT SEVERAL NEEDLES WERE CLOGGED, AND ONE NEEDLE HAD DETACHED FROM ITS CORRESPONDING SYRINGE. TO SUPPORT THE INVESTIGATION, FIVE SAMPLES WERE PROVIDED WITHOUT PLASTIC SHIELDS OR PACKAGING. A VISUAL INSPECTION REVEALED THAT THE TOP PORTION OF EACH NEEDLE WAS BENT APPROXIMATELY 30 DEGREES, WHILE THE REMAINDER OF THE NEEDLE APPEARED TO BE IN GOOD CONDITION. EACH SAMPLE WAS ASSEMBLED WITH A SYRINGE CONTAINING SALINE SOLUTION. NO LEAKAGE WAS OBSERVED AT THE INTERFACE BETWEEN THE SYRINGE AND NEEDLE HUB OR IN ANY OTHER AREA. HOWEVER, THE SOLUTION COULD NOT BE EXPELLED, CONFIRMING THAT THE NEEDLES WERE CLOGGED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED FOR MATERIAL NUMBER 302890, COVERING LOTS 3052475, 3198060, AND 3081900. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE ANALYSIS OF THE RETURNED SAMPLES, THE REPORTED ISSUE OF CLOGGED NEEDLES HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 30GA 7/8IN BSG CLEAR HUB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 302890 BATCH#: 3052475, 3198060, 3081900. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED OUR XX DEPARTMENT HAS ASKED THAT I COMMUNICATE THE ONGOING ISSUES WE HAVE OBSERVED AND RECEIVED WITH PN 302890. OVER THE LAST 2 YEARS, WE HAVE RECEIVED MULTIPLE COMPLAINTS REGARDING THIS PRODUCT BEING CLOGGED. IN MID-2024, WE SUBMITTED TWO OPEN COMPLAINTS TO YOUR TEAM REGARDING THIS ISSUE (REFERENCE NUMBERS (B)(4)), AT A TIME WHEN WE HAD ONLY THREE CUSTOMER COMPLAINTS. ADDITIONAL INFORMATION RECEIVED ON 23-SEP-2025: LOT NUMBER IS 3081900, SORRY ABOUT THE TYPO MOST CASES THEY REALIZED THE NEEDLE WAS CLOGGED AND GOT ANOTHER ONE TO DO THE PROCEDURE. WE DID HAVE ONE CUSTOMER TELL US THAT THE NEEDLE DID REMOVE ITSELF FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459257 BD NEEDLE 30GA 7/8IN BSG CLEAR HUB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 3198060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown