BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO

    MDR report key: 24104587 · Received January 16, 2026

    Report

    Report Number
    1911916-2026-00016
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 28, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THAT SOME NEEDLES WERE DAMAGED IN THE HUB AREA. AS NO PHYSICAL SAMPLE WAS RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED TO THE QUALITY TEAM FOR REVIEW. THE IMAGE APPEARS TO SHOW THE LOWER PORTION OF THE NEEDLE HUB; HOWEVER, THE PHOTOGRAPH IS BLURRED, AND IT IS UNCLEAR WHETHER THE OBSERVED CONDITION REPRESENTS DAMAGE TO THE EDGE OR THE PRESENCE OF PLASTIC FLASH. DUE TO THE LIMITED QUALITY AND SCOPE OF THE PHOTOGRAPH, NO ADDITIONAL INFORMATION COULD BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 302047, LOT 5202785. THIS REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT TO DATE. BASED ON THE AVAILABLE INFORMATION, INCLUDING THE PHOTOGRAPHIC REVIEW, THE REPORTED CUSTOMER SYMPTOM IS ACKNOWLEDGED. HOWEVER, IN THE ABSENCE OF THE ACTUAL PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    PR (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT SOME NEEDLES WERE DAMAGED IN THE HUB AREA. TO SUPPORT THE INVESTIGATION, THREE SAMPLES WITH NO PACKAGING AND ONE PHOTOGRAPH WAS PROVIDED TO THE QUALITY TEAM FOR REVIEW. A VISUAL INSPECTION REVEALED NO DEFECTS OR IMPERFECTIONS. EACH SAMPLE WAS SUBSEQUENTLY ASSEMBLED TO A SYRINGE FILLED WITH SALINE SOLUTION. THE SOLUTION WAS EXPELLED AT A NORMAL FLOW RATE, AND NO LEAKAGE WAS DETECTED. THE IMAGE APPEARS TO SHOW THE LOWER PORTION OF THE NEEDLE HUB; HOWEVER, THE PHOTOGRAPH IS BLURRED, AND IT IS UNCLEAR WHETHER THE OBSERVED CONDITION REPRESENTS DAMAGE TO THE EDGE OR THE PRESENCE OF PLASTIC FLASH. DUE TO THE LIMITED QUALITY AND SCOPE OF THE PHOTOGRAPH, NO ADDITIONAL INFORMATION COULD BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 302047, LOT 5202785. THIS REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT TO DATE. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER REPORTED SYMPTOM COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO NEEDLE HUB WAS CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO-NEEDLE HUB HOLE / CRACKED / DAMAGED IT WAS REPORTED THAT DURING THE FAI WHICH WAS PERFORMED ON (B)(6) 2025, AT THE BEGINNING OF THE LUBRICATION PROCESS FOR NEEDLE BATCH BD-5202785 ON MACHINE MP-203 - IT WAS DISCOVERED THAT SOME NEEDLES WERE DAMAGED IN THE HUB AREA OF THE NEEDLE. DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166103 BD NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5202785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown