BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CATHETER TIP 50ML

    MDR report key: 21885185 · Received April 22, 2025

    Report

    Report Number
    1911916-2025-00299
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    December 13, 2024
    Report Date
    April 23, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    KYZ
    UDI-DI
    30382903096207
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THERE ARE PUNCTURES IN THE PLASTIC PACKAGING. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PACKAGING BLISTER BOTTOM WEB WITH ROUNDED MARKS FROM THE PACKAGING PROCESS; THEY ARE NOT HOLES. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309620, LOT 4172759. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL #:309620. BATCH#:4172759. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A PUNCTURES IN PLASTIC PACKAGING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE FOLLOW UP WITH (B)(6) FOR THE PRODUCT CONCERN OUTLINED BELOW WITHIN 3 BUSINESS DAYS; AND ADVISE OF ANY SPECIAL SHIPPING INSTRUCTIONS FOR PICK UP, COURIER OR DISCARDING OF PRODUCT. PLEASE INVESTIGATE AND FOLLOW UP WITH A WRITTEN REPORT FROM YOUR QUALITY ASSURANCE AS TO YOUR FINDINGS AND RESOLUTIONS. PRODUCT CONCERN TICKET NUMBER: (B)(4). DATE OF INCIDENT: (B)(6) 2024. HOSPITAL: (B)(6). DEPARTMENT: (B)(6). PRODUCT: SYR LL TIP 50CC. VMID: (B)(4). LOT NUMBER: MULTIPLE LOTS. PRODUCT EXPIRY DATE: 31-MAY-2029. NUMBER OF DEFECTIVE PRODUCT(S): 1. IS SAMPLE AVAILABLE: NO. CONCERN DESCRIPTION: LOOKS LIKE SMALL PUNCTURES IN PLASTIC PACKAGING. THANK YOU IN ADVANCE FOR YOUR FOLLOW-UP ON THIS PRODUCT CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674533 SYRINGE CATHETER TIP 50ML SYRINGE, IRRIGATING (NON DENTAL) KYZ BECTON DICKINSON 4172759 30382903096207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown