BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE

    MDR report key: 15411697 · Received September 13, 2022

    Report

    Report Number
    1213809-2022-00568
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 8, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096596
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. INVESTIGATION SUMMARY: ONE PHOTO OF A 1ML SYRINGE (P/N ¿ 309659) WAS RECEIVED AND EVALUATED. THE IMAGE SHOWS ONE LOOSE SYRINGE WITH THE PLUNGER ROD PARTIALLY REMOVED FROM THE BARREL WITH DAMAGE TO THE PLUNGER ROD ABOUT A ½¿ FROM THE THUMBREST. THERE IS DAMAGE TO ONE SIDE OF THE PLUNGER ROD WITH MATERIAL REMOVED AND PUSHED OVER TO THE OTHER SIDE OF THE PLUNGER ROD. THE OBSERVED CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE PLUNGER ROD DAMAGED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. (B)(4). THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 1090659 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER IN THE BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE WAS DAMAGED AND COULDN'T BE PULLED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE HOSPITAL FOUND ONE SYRINGE HAS A... ISSUE THAT CANNOT BE PULLED OUT DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS REPORTED DEFECT? WE HAVE RECEIVED CUSTOMER COMPLAINTS DUE TO THIS SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391681 BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1090659 00382903096596

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown