BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML SALINE XS

    MDR report key: 18319085 · Received December 13, 2023

    Report

    Report Number
    3002682307-2023-00355
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 20, 2023
    Report Date
    April 3, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    UDI-DI
    00382903065721
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MATERIAL 306572, BATCH 3143950. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH, AND THERE WERE NO POSSIBLE NON-CONFORMANCES WHICH COULD CONTRIBUTE TO THE COMPLAINT VERBATIM REPORTED BY THE CUSTOMER. AS THERE WAS NO PHYSICAL SAMPLE OR PHOTOGRAPH AVAILABLE FOR ANALYSIS WE WERE UNABLE TO CONFIRM THE DEFECT AND DETERMINE THE ROOT CAUSE. IF A PHYSICAL SAMPLE IS FORTHCOMING, THE COMPLAINT CAN BE RE-INVESTIGATED AND A COMPLETE ANALYSIS WILL BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10ML SALINE XS PACKAGING IS RIPPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION OF PRODUCT: SYRINGE SALINE XS P/FLUSH 10ML 30EA/BX 8BX/CA LOT OR S/N: N/A COMPLAINT CATEGORY: DAMAGED / BROKEN REPORTABLE: NO INCIDENT DATE: 20 NOV 2023 HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): WE RECEIVED A PRODUCT COMPLAINT REGARDING ITEM ALSO - POSI FLUSH PRE-FILLED SYRINGE 0.9% SODIUM CHLORIDE. WHEN THE END USER OPENED THE BOX THE PACKAGE WAS RIPPED ON THE BACK AND THE PLASTIC OVERING WAS CRACKED OPEN. THIS PRODUCT IS SUPPOSED TO BE STERILE. THE SITE AFFECTED IS COMPLAINT NOTICED: PRIOR TO USE PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO. QTY AFFECTED: 1 EA. SAMPLES AVAILABLE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273257 BD SYRINGE 10ML SALINE XS SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 3143950 00382903065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown