BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETYGLIDE

    MDR report key: 24210916 · Received January 29, 2026

    Report

    Report Number
    1213809-2026-00038
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 12, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4). SUPPLEMENTAL MDR - NEEDLE PULLED OUT OF HUB. NINETY SAMPLES WERE RECEIVED IN SEALED BLISTER PACKAGING AND UNDERWENT A VISUAL INSPECTION, DURING WHICH NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. TWENTY SAMPLES WERE THEN RANDOMLY SELECTED FOR CANNULA PULL FORCE TESTING, AND THE RESULTS WERE WITHIN THE ACCEPTABLE RANGE. BASED ON THE INVESTIGATION AND ANALYSIS OF THE SAMPLES, THE REPORTED SYMPTOM COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305916, LOT 5233985. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WAS APPROVED FOR SHIPMENT, AND IS IN COMPLIANCE WITH APPLICABLE PRODUCT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X1 RB NEEDLE PULLED OUT OF HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. DISTRIBUTION IS PROVIDING NOTIFICATION OF THE FOLLOWING PRODUCT COMPLAINT, AND WE TRUST THAT YOU WILL TAKE THE APPROPRIATE CORRECTIVE ACTIONS TO RESOLVE THIS ISSUE. THE INFORMATION RELEVANT TO THE COMPLAINT IS AS FOLLOWS: O&M COMPLAINT RECORD NUMBER(S): (B)(4) O&M PRODUCT NUMBER- 0723305916 SUPPLIER PRODUCT NUMBER: 305916 SUPPLIER PRODUCT DESCRIPTION: NEEDLE HYPO SAF 25GA QUANTITY INVOLVED: 2BX LOT# 5233985 SAMPLE AVAILABLE:Y IS INVESTIGATION RESPONSE REQUESTED: Y. CUSTOMER REIMBURSEMENT REQUEST IS AS FOLLOWS: DC#: 78 O&M PO# (B)(4) CREDIT OR REPLACEMENT REQUEST: NA. THE DETAILS OF THE REPORTED COMPLAINT: (B)(4). DATE OF EVENT: 1/05/2026 VACCINE WAS GIVEN TO PATIENT, UPON PULLING NEEDLE OUT OF ARM (POST ADMIN) THE NEEDLE DETACHED FROM THE HUB/REST OF DEVICE AND WAS LODGED IN ARM OF PATIENT. NEEDLE WAS MANUALLY REMOVED FROM PT'S ARM, INTACT. NO HARM WAS DONE TO THE PATIENT. SHE WAS DISCHARGED HOME. NURSE CALLED THE PATIENT LATER IN THE DAY, PATIENT REPORTED NO UNUSUAL PAIN ON REDNESS AT SITE. WAS PATIENT OR END-USER INJURED: N WHEN WAS INCIDENT NOTICED: DURING USE WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y WAS ANY MEDICAL TREATMENT REQUIRED: N DID CUSTOMER FILE A REPORT WITH HEALTH AUTHORITY(IES): Y.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270506 SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5233985 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other