BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 25320029 · Received May 28, 2026

    Report

    Report Number
    1911916-2026-00248
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903051809
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT A BLACK SPOT WAS OBSERVED IN THE SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITH AN OPENED BLISTER PACKAGE WAS RETURNED AND EVALUATED BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED AT 30X MAGNIFICATION, WHICH DID NOT IDENTIFY ANY DAMAGE, DEFECTIVE GRIND, OR HOOK RELATED ISSUES. THE BEVELS AND ETCHING WERE FOUND TO BE ACCEPTABLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR MATERIAL NUMBER 305180, LOT 4082888. THIS REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE MANUFACTURING OF THE LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH APPLICABLE SPECIFICATIONS. ADDITIONALLY, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT TO DATE. BASED ON THE INVESTIGATION AND THE ANALYSIS OF THE RETURNED SAMPLE, THE CONDITION DESCRIBED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED, NEEDLE BLUNT FILL TIP 18 GAUGE X 1.5 INCH, AFTER ASPIRATING THE CONTRAST, A BLACK SPOT WAS NOTED IN THAT CONTRAST/SYRINGE. CUSTOMER DESCRIPTION: WRITER PREPPED THE DEFINITY BOTTLE/VIAL BY PUTTING IT IN THE VIALMIX MACHINE. AFTER IT WAS MIXED, WRITER REMOVED THE TOP PLASTIC COVER, AND THEN WIPED THE VIALS RUBBER CAP. A 25 GAUGE NEEDLE (BD LOT # REKX3139) WAS PUNCTURED THROUGH THE RUBBER CAP FOR VENTING. THEN A 18 GAUGE BD BLUNT FILL NEEDLE (LOT# 4082888) WAS CONNECTED TO THE 10 MG SYRINGE. THEN THAT 18 G NEEDLE WAS PUNCTURED THROUGH THE DEFINITY RUBBER CAP TO ASPIRATE THE CONTRAST. AFTER ASPIRATING THE CONTRAST, A BLACK SPOT WAS NOTED IN THAT CONTRAST/SYRINGE. WRITER LOOKED CLOSER, BUT IT SOMEHOW IT SEEMED TO HAVE VANISHED. THE DIMLY LIT ROOM DID NOT HELP EITHER. THE WRITER REMOVED THAT NEEDLE/SYRINGE CONTAINING THE CONTRAST FROM THE DEFINITY VIAL/BOTTLE, THEN DRAINED A FEW DROPS OUT TO HAVE APPROX. VOLUME OF 1.33CC OF CONTRAST IN THAT SYRINGE. THEN WRITER PUNCTURED/INSERTED THAT NEEDLE/SYRINGE THROUGH A RUBBER CAP OF A 10CC VIAL 0.9 SALINE TO ASPIRATE THE SALINE SOLUTION TO MIX WITH CONTRAST. WHILE WRITER WAS ASPIRATING THE 0.9 NACL IN THE SYRINGE AND IT WAS MIXING WITH THE CONTRAST, WRITER NOTED THAT BLACK SPOT AGAIN WHICH UPON CLOSER LOOK IT APPEARS TO BE A SMALL PIECE OF RUBBER. WRITER STOPPED ASPIRING THE SALINE AND REMOVED THE NEEDLE/SYRINGE OFF OF THE VIAL CAP OF THE 0.9 SALINE. WRITER SHOWED THE SYRINGED TO DEPARTMENT'S EDUCATOR. THE CONTRAST FILLED NEEDLE/SYRINGE THEN SECURED. EXTERNAL SURFACE WAS WIPED WITH KIMTECH PURE DISINFECTANT. MANUFACTURER CODE/MODEL: 305180 SERIAL OR LOT NUMBER: (B)(6) EXPIRY DATE: 2029-06-30 NUMBER OF DEVICES: 1 THERE WAS NO SERIOUS HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213948 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 4082888 00382903051809

    Patients

    Seq Age Sex Outcome Treatment
    1