BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 11704602 · Received April 21, 2021

    Report

    Report Number
    9616657-2021-00043
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/10/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 9213635. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SUPPLIED SAMPLE WAS RECEIVED OPENED WITHOUT THE BLISTER PACKAGING AND IT DISPLAYED AN UNDERFILL OF SALINE. IT IS POSSIBLE THAT AN INTERMITTENT AND ISOLATED ISSUE WITH THE TIP CAP TORQUE OCCURRED, RESULTING IN LEAKAGE OF SALINE THROUGH THE TIP CAP WHICH EVAPORATED IN THE BLISTER PACKAGING. HOWEVER, AS THE SAMPLE WAS OPENED, THIS EXACT CAUSE CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% EXPERIENCED BEING A PREFILLED SYRINGE WITH A FILL THAT WAS LESS THAN DESIGN SPECIFICATIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD-POSIFLUSH IS FILLED WITH LESS THAN 3ML.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (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 THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% EXPERIENCED BEING A PREFILLED SYRINGE WITH A FILL THAT WAS LESS THAN DESIGN SPECIFICATIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD-POSIFLUSH IS FILLED WITH LESS THAN 3ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596205 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PREFILLED SALINE SYRINGE NGT BECTON, DICKINSON AND CO. 9213635

    Patients

    Seq Age Sex Outcome Treatment
    1