BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB

    MDR report key: 21845524 · Received April 15, 2025

    Report

    Report Number
    1213809-2025-00276
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 29, 2025
    Report Date
    June 3, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052715
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR ADDITIONAL INFORMATION / CORRECTION. ADVERSE TYPE SHOULD BE BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM. CORRECT EVENT/PRODUCT PROBLEM SHOULD BE SAFETY MECHANISM FAILURE. ANNEX A CODE SHOULD BE A1501 - ACTIVATION PROBLEM. ANNEX E CODE SHOULD BE E2119 - UNINTENDED RADIATION EXPOSURE. ANNEX F CODE SHOULD BE F12 - SERIOUS INJURY/ ILLNESS/ IMPAIRMENT.

    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)(6) - SUPPLEMENTAL MDR - SAFETY MECHANISM FAILURE. TWO PHOTOS OF A 3 ML INTEGRA SYRINGE (MATERIAL 305271, BATCH 1081332) WERE RECEIVED AND REVIEWED. THE FIRST IMAGE SHOWS A FULLY ASSEMBLED LOOSE SYRINGE WITH THE CAP DETACHED, PLACED NEXT TO A SEALED PACKAGE VIEWED FROM THE TOP WEB SLIP SIDE, DISPLAYING ALL REQUIRED LABELING. THE SECOND IMAGE APPEARS TO SHOW THE SAME LOOSE SYRINGE ALONGSIDE A FULLY ASSEMBLED SYRINGE WITHIN A SEALED PACKAGE, VIEWED FROM THE TRANSPARENT BOTTOM WEB. NO DEFECTS WERE OBSERVED IN EITHER IMAGE. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED, A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1081332. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED ON 01-MAY-2025. PATIENT ALLEGES THAT THE SUBJECT NEEDLE WOULD NOT RETRACT UNLESS SIGNIFICANT PRESSURE WAS PUT ON IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB RETRACTED AS INTENDED AND PATIENT REPORTED HE COULD NOT FIND NEEDLE AFTER INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CONTACT NAME: (B)(6). CONTACT NUMBER: (B)(6). CONTACT EMAIL (IF AVAILABLE): (B)(6). ITEM(S): 305271. LOT(S):1081332. DATE INCIDENT OCCURRED: (B)(6) 2025. WAS THE PATIENT IMPACTED? YES COULD NOT FIND NEEDLE AFTER INJECTION SO WENT TO THE EMERGENCY ROOM FOUND OUT THAT IT IS A RETRACTABLE NEEDLE. IF YES, DESCRIBE: PRINT TOO SMALL TO SEE. IS A SAMPLE AVAILABLE? YES. CUSTOMER RESPONDED ON (B)(6) MY ADDRESS IS: I WAS IN THE URGENT CARE FOR 4 HOURS AND WAS X-RAYED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349877 BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 1081332 30382903052715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other