BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 24791164 · Received April 6, 2026

    Report

    Report Number
    1213809-2026-00176
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059010
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 A HAIR WAS PROTRUDING FROM THE CAP. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM RECEIVED ONE SAMPLE WITH AN OPENED BLISTER PACKAGE AND TWO PHOTOGRAPHS FOR EVALUATION. A VISUAL INSPECTION CONFIRMED A HAIR TRAPPED BETWEEN THE NEEDLE HUB AND THE PLASTIC SHIELD. THE PHOTOGRAPHS PROVIDED CORRESPOND TO THE SAMPLE RECEIVED. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE OBSERVED. THIS CONDITION COULD RESULT FROM A GOWNING NONCONFORMANCE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305901, LOT 5080421. THE REVIEW CONFIRMED THAT ALL REQUIRED VISUAL INSPECTIONS WERE PERFORMED AND THAT NO QUALITY NOTIFICATIONS WERE GENERATED RELATED TO THE REPORTED CONDITION. THE LOT WAS INSPECTED AND ACCEPTED IN ACCORDANCE WITH THE INSPECTION CONTROL PLAN AND WAS APPROVED FOR SHIPMENT. IN ADDITION, DEVICE HISTORY DOCUMENTATION WAS REVIEWED FOR EACH LOT OF NEEDLES USED IN THE MANUFACTURE OF THE FINAL LOT, AND NO RECORDS OF THIS DEFECT TYPE WERE IDENTIFIED THROUGHOUT THE PRODUCTION RUN. THE SAMPLE WILL BE USED FOR ASSOCIATE AWARENESS. BASED ON THE INVESTIGATION AND RETURNED SAMPLE EVALUATION, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB CONTAINED FOREIGN MATTER. COMPLAINT VIA PHONE. CASE DESCRIPTION: THERE IS A HAIR STICKING OUT OF THE CAP, SHE CAN EVEN SEE THE HAIR FOLLICLE. PRODUCT: BD SAFETYGLIDE¿ NEEDLE 25 G X 5/8 IN. REF#: 305901, LOT#: 5080421. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 19-MAR-2026. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEAR MISS. NO PATIENT HARM OCCURRED. NURSE WENT TO ATTACH THE NEEDLE TO SYRINGE BUT COULD CLEARLY SEE THE HAIR STICKING OUT OF THE CAP AND DID NOT USE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600580 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5080421 00382903059010

    Patients

    Seq Age Sex Outcome Treatment
    1