BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE

    MDR report key: 7222599 · Received January 26, 2018

    Report

    Report Number
    1213809-2018-00006
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 2, 2018
    Report Date
    March 19, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THREE SAMPLES WERE RECEIVED FOR THIS COMPLAINT. TWO OF THE SAMPLES RECEIVED HAD OPENED PACKAGES WITH SYRINGE INSIDE AND ONE OF THEM WAS AN EMPTY PACKAGE. THE SAMPLES WITH OPENED PACKAGES ARE FROM BATCH #7212643. THE EMPTY PACKAGE SAMPLE IS FROM BATCH #7155706. THE SYRINGES WERE VISUALLY EVALUATED. BOTH SYRINGES PRESENT MISSING GRADUATED SCALE. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION PERFORMED. BATCH 7155706 WAS RELEASED ON 07/02/2017 WITH (B)(4) PIECES. BATCH 7212643 WAS RELEASED ON 08/24/2017 WITH (B)(4) PIECES. NO QUALITY NOTIFICATIONS WERE CREATED FOR MISSING PRINT OR EMPTY PACKAGES DURING THE PRODUCTION OF BATCH 7155706 AND 7212643. BATCH 7155706 AND 7212643 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO SPECIFIC ROOT CAUSE WAS IDENTIFIED FOR THE PRODUCT DEFECTS ASSOCIATED WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7155706. MEDICAL DEVICE EXPIRATION DATE: 05/31/2022. DEVICE MANUFACTURE DATE: 06/04/2017. MEDICAL DEVICE LOT #: 7212643. MEDICAL DEVICE EXPIRATION DATE: 07/31/2022. DEVICE MANUFACTURE DATE: 07/31/2017. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE THE SYRINGES WERE RECEIVED WITHOUT CALIBRATION MARKS AND PACKAGES DID NOT CONTAIN A SYRINGE INSIDE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65082 BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE TUBERCULIN SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other