BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 24796290 · Received April 6, 2026

    Report

    Report Number
    1213809-2026-00179
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 21, 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

    B3. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. COMPLAINT VIA PHONE. CASE DESCRIPTION: THE BD SAFETYGLIDE¿ NEEDLE 25 G X 5/8 IN IS PRESENTING ISSUES WITH A COUPLE OF SAMPLES, THE CUSTOMER INFORMED THAT THE NEEDLE DETACHED FROM THE HUB AND THE NEEDLE GOT STUCK IN THE HUB. HE MENTIONED THAT THIS HAPPENED THREE TIMES. PRODUCT: BDSAFETYGLIDE¿ NEEDLE 25 G X 5/8 IN. REF#: 305901, LOT#: 5080421, CUSTOMER RESPONSE ON 25-MAR-2026. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? AROUND 09-03-2026. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE REPORTED BY THE PATIENT. 3. COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR RETURN SO WE CAN INVESTIGATE FURTHER? NO SAMPLES AVAILABLE. CUSTOMER RESPONSE ON (B)(6) 2026. DID THE NEEDLE DETACH FROM THE HUB AND REMAIN IN PATIENT? YES. THE NEEDLE DETACHED FROM THE HUB. (THE NEEDLE WAS STUCK IN THE VIAL- NOT THE PATIENT). IF YES, WAS NEEDLE REMOVED FULLY INTACT WITH NO FURTHER FOLLOW UP? THE NEEDLE WAS REMOVED INTACT (IT GO STUCK IN THE VIAL-RUBBER STOPPER WHILE ATTEMPTING TO WITHDRAW THE MEDICATION FROM THE VIAL).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265106 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5080421 00382903059010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other