BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 11289778 · Received February 5, 2021

    Report

    Report Number
    2243072-2021-00241
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 8, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D.3. MEDICAL DEVICE MANUFACTURER: FRANKLIN LAKES, NJ. G.2. MANUFACTURING LOCATION: FRANKLIN LAKES, NJ.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 UNSPECIFIED BD¿ SYRINGE LEAKED OZONYL PAST THE STOPPER, AND 2 SYRINGES HAD DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED VIA SURVEY RESPONSE THAT THE CLINICIAN ENCOUNTERED LEAKAGE OF OZONYL PAST THE STOPPER (1), REACTION AT THE INJECTION SITE (1), PLUNGER ROD BROKEN/DAMAGED (2), DIFFICULTY DRAWING FLUID/MEDICATION INTO SYRINGE (4) AND PACKAGE DIFFICULT TO OPEN/TEARS (3) RELATED TO LUER LOK AND LUER SLIP TIP SYRINGES.". "WHAT FLUID LEAKED? OZONYL USED TO RELIEVE COUGH IN LUNG DISEASES. WHERE DID THE LEAKAGE COME FROM? FROM THE SYRINGE PLUNGER.".

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. 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 · 1

    IT WAS REPORTED THAT 1 UNSPECIFIED BD¿ SYRINGE LEAKED OZONYL PAST THE STOPPER, AND 2 SYRINGES HAD DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED VIA SURVEY RESPONSE THAT THE CLINICIAN ENCOUNTERED LEAKAGE OF OZONYL PAST THE STOPPER (1), REACTION AT THE INJECTION SITE (1), PLUNGER ROD BROKEN/DAMAGED (2), DIFFICULTY DRAWING FLUID/MEDICATION INTO SYRINGE (4) AND PACKAGE DIFFICULT TO OPEN/TEARS (3) RELATED TO LUER LOK AND LUER SLIP TIP SYRINGES." "WHAT FLUID LEAKED? OZONYL USED TO RELIEVE COUGH IN LUNG DISEASES. WHERE DID THE LEAKAGE COME FROM? FROM THE SYRINGE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185985 UNSPECIFIED BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1