BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 12249382 · Received July 29, 2021

    Report

    Report Number
    9616657-2021-00069
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: 8/23/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1132880. 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 AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, FOREIGN MATTER WAS OBSERVED ON THE TIP CAP COMPONENT. PER THE INVESTIGATION CONCLUSIONS, IT IS POSSIBLE THAT THE FOREIGN MATTER WAS ASSOCIATED WITH THE MOLDING MACHINE; HOWEVER, AN EXACT CAUSE CANNOT BE DETERMINED AS THIS WAS AN ISOLATED INCIDENT WITH NO ISSUES DETECTED DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% HAD FOREIGN MATTER IN THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "CONTAMINATION AT THE CLOSING CAP."

    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 THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% HAD FOREIGN MATTER IN THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "CONTAMINATION AT THE CLOSING CAP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145368 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 1132880

    Patients

    Seq Age Sex Outcome Treatment
    1