BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CATHETER TIP 50ML

    MDR report key: 22904326 · Received August 27, 2025

    Report

    Report Number
    1911916-2025-00622
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 16, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    KYZ
    UDI-DI
    00382903096206
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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)(6) FOLLOW UP. A SEALED DEVICE WAS REPORTED TO BE CONTAMINATED. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, A SINGLE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGE DEPICTS A SYRINGE WITHIN ITS BLISTER PACKAGING AND A TOP WEB. DISCOLORATION IS VISIBLE AT THE BOTTOM OF THE SYRINGE, INCLUDING THE TIP, WHILE NO OTHER DEFECTS OR IRREGULARITIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER 309620, LOT 5043318. THE ASSESSMENT DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE REPORTED SYMPTOM HAS BEEN CONFIRMED. HOWEVER, IN THE ABSENCE OF THE PHYSICAL SAMPLE, IT WAS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE.

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: IT WAS REPORTED THAT NEXT, I SEND FOR YOUR SOCIALIZATION THE FOLLOWING INCIDENT THAT IS PRESENTED IN THE SERVICE OF CENTRAL LIMONAR PHARMACY WITH THE ITEM: 1000000552 SYRINGE 50ML CATHETER TIP 309620 BD LOT: 5043318 (1 UND), TAKING INTO ACCOUNT THE ABOVE WE ARE ATTENTIVE TO TECHNICAL RESPONSE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. HAS THERE BEEN ANY DAMAGE TO PATIENTS OR HEALTH PERSONNEL? NO. COULD YOU PLEASE CONFIRM THE QUANTITIES AFFECTED? 1. WHEN DID THIS INCIDENT OCCUR, BEFORE, AFTER OR DURING THE PROCEDURE? BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405097 SYRINGE CATHETER TIP 50ML SYRINGE, IRRIGATING (NON DENTAL) KYZ BECTON DICKINSON 5043318 00382903096206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown