BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 14215117 · Received April 26, 2022

    Report

    Report Number
    9616657-2022-00012
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    March 28, 2022
    Report Date
    May 27, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 05-MAY-2022. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 0021182. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, EMBEDDED FOREIGN MATTER WAS OBSERVED ON THE PLUNGER ROD COMPONENT OF THE SYRINGE WITHIN THE UNOPENED BLISTER PACKAGING. THE PHYSICAL SAMPLE WAS SENT FOR FOURIER-TRANSFORM INFRARED (FTIR) SPECTROSCOPY, IN ORDER TO IDENTIFY THE FOREIGN MATERIAL. THE FTIR ANALYSIS CONFIRMED THAT THE FOREIGN MATERIAL WAS COMPOSED OF OLEFIN FIBER OR A POLYOLEFIN POLYMER MATERIAL. IT HAS BEEN DETERMINED THAT THE FOREIGN MATERIAL MOST LIKELY RESULTED DUE TO A STOPPAGE IN THE MOLDING MACHINERY WHICH ALLOWED FOR DEGRADATION OF THE MATERIAL AT THE TIP. CAPA#3251946 WAS INITIATED FOR THIS ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PLUNGER HAD FOREIGN MATTER ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE PLUNGER IS DIRTY, IT SEEMS TO BE POLLUTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PLUNGER HAD FOREIGN MATTER ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE PLUNGER IS DIRTY, IT SEEMS TO BE POLLUTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792359 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 0021182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown