BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 7890546 · Received September 19, 2018

    Report

    Report Number
    3003152976-2018-00405
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 30, 2018
    Report Date
    October 5, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHYSICAL SAMPLE AND TWO PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE SAMPLES, THE SYRINGE TIP WAS OBSERVED DAMAGED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1802233 THAT COULD HAVE CONTRIBUTED TO THE REPORTED/OBSERVED DEFECT. AREAS IN WHICH THE PRODUCT MAY COME INTO CONTACT WITH THE MACHINERY ARE PROTECTED TO AVOID POTENTIAL DAMAGES DURING TRANSPORT. THE EXACT LOCATION OF THE IMPACT CANNOT BE IDENTIFIED. THE OBSERVED DEFECT WAS CAUSED BY AN UNDETECTED HIT DURING THE TRANSPORT OR MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE THERE WAS AN ISSUE WITH MOLDING DEFECT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.(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 WITH THE USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS AN ISSUE WITH MOLDING DEFECT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732162 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802233

    Patients

    Seq Age Sex Outcome Treatment
    1 Other