BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8387158 · Received March 4, 2019

    Report

    Report Number
    9616657-2019-00132
    Event Type
    Injury
    Date Received
    March 4, 2019
    Date of Event
    January 1, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR: COMPLAINT TRENDING REVIEW OF THE LOT FOR THIS ISSUE REVEALS THIS IS THE SEVENTH COMPLAINT. THE NON-CONFORMANCES WERE REVIEWED FOR THIS BATCH, AND THERE WAS NO RECORD OF NON-CONFORMANCE WHICH COULD CONTRIBUTE TO THE COMPLAINT VERBATIM REPORTED BY THE CUSTOMER. NO SAMPLE AVAILABLE. CONCLUSION(S): THERE IS NO EVIDENCE THAT POSIFLUSH SYRINGE WAS RESPONSIBLE FOR THIS REACTION. A POTENTIAL CONTRIBUTORY FACTOR MAYBE OTHER MEDICINAL PRODUCTS IN USE OR ADMINISTERED AT THE TIME THE PATIENT¿S PORT WAS FLUSHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED "OEDEMA" IN THE ANKLES AFTER THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% HAD BEEN USED TO "FLUSH THE LINE BEFORE AND AFTER EACH INFUSION". HOWEVER, THERE WAS NO MEDICAL INTERVENTION REPORTED, AND NO FURTHER INFORMATION REGARDING THE PATIENT'S OUTCOME HAS BEEN RECEIVED. AS REPORTED BY THE CUSTOMER, "DETAILS: REPORT RECEIVED TO ADVISED OEDEMA IDENTIFIED IN PATIENT ANKLES. NO FURTHER INFORMATION OBTAINED ON OUTCOME OF PATIENTS' CONDITION. PRODUCT: 306572 PFS 0.9%P/FLUSH XS SALINE 10ML ST - USE TO FLUSH LINE BEFORE AND AFTER EACH INFUSION. BATCH:8242797".

    Additional Manufacturer Narrative · 1

    (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 PATIENT DEVELOPED "OEDEMA" IN THE ANKLES AFTER THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% HAD BEEN USED TO "FLUSH THE LINE BEFORE AND AFTER EACH INFUSION". HOWEVER, THERE WAS NO MEDICAL INTERVENTION REPORTED, AND NO FURTHER INFORMATION REGARDING THE PATIENT'S OUTCOME HAS BEEN RECEIVED. AS REPORTED BY THE CUSTOMER, "DETAILS: REPORT RECEIVED TO ADVISED OEDEMA IDENTIFIED IN PATIENT ANKLES. NO FURTHER INFORMATION OBTAINED ON OUTCOME OF PATIENTS' CONDITION. PRODUCT - 306572 PFS 0.9%P/FLUSH XS SALINE 10ML ST - USE TO FLUSH LINE BEFORE AND AFTER EACH INFUSION. BATCH:8242797."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182067 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PRE-FILLED SYRINGE NGT BECTON, DICKINSON AND CO. 8242797

    Patients

    Seq Age Sex Outcome Treatment
    1 Other