BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

    MDR report key: 8125391 · Received December 3, 2018

    Report

    Report Number
    9616657-2018-00064
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    September 12, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BATCH CODE 8123598 FOR MATERIAL NUMBER 306572 WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 8123598 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. AS NEITHER A PHYSICAL SAMPLE NOR A PICTURE SAMPLE WAS AVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. DUE THE ABSENCE OF A SAMPLE OR PHOTO THE COMPLAINT COULD NOT BE SUBSTANTIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH LEAKAGE PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    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 POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH LEAKAGE PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965763 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE SYRINGE FMF BECTON, DICKINSON AND CO. 8123598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other