BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 7026362 · Received November 13, 2017

    Report

    Report Number
    1213809-2017-00265
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 20, 2017
    Report Date
    January 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH 6090782 (P/N 309658): MANUFACTURING DATES: 05/03/2016 ¿ 05/04/2016. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. SILICONE TESTING WAS PERFORMED AS PER REQUIREMENT WITH ALL TEST RESULTS WITHIN ACCEPTABLE RANGE PER PRODUCT SPECIFICATION. BATCH 6090782 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER ZIP CODE : (B)(6). 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 THAT A BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ MALFUNCTIONED DURING USE AS THE NURSES REPORTED HAVING DIFFICULTY WITH THE PLUNGER. REPORTED DIFFICULTY DRAWING UP VACCINE AND INJECTING VACCINE INTO PATIENTS - EXPERIENCING SOME RESISTANCE. RESULTING IN ONE INCIDENT OF VACCINE THAT DID NOT INJECTED INTO PATIENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803036 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6090782 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other