BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL

    MDR report key: 8514281 · Received April 15, 2019

    Report

    Report Number
    9616657-2019-00183
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    January 15, 2019
    Report Date
    April 30, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR WAS COMPLETED AND NO NON-CONFORMANCES WERE SEEN FOR THIS BATCH THAT COULD CONTRIBUTE TO THE COMPLAINT REPORTED. NEITHER SAMPLE NOR PHOTO WERE RETURNED. 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. BASED ON THE INFORMATION PROVIDED, IT IS MORE PROBABLE THAN NOT THAT THE SYMPTOMS DESCRIBED MAY BE AN ALLERGIC REACTION; HOWEVER, IT IS HIGHLY IMPROBABLE THAT THIS REACTION WAS PRODUCED BY THE NORMAL SALINE IN THE BD POSIFLUSH PRODUCT. DURING THE PERIOD 2017-2019, THERE ARE NO OTHER ADVERSE CUSTOMER COMPLAINT TRENDS FOR THE COMPLAINT CATEGORY OF ALLERGIC REACTION, APART FROM FRESENIUS KABI UK. THERE ARE NO KNOWN ALLERGIES TO NORMAL SALINE, EITHER TOPICAL OR WITHIN THE BODY. IT IS MOST LIKELY THAT WHATEVER FLUID WAS IN THE IV LINE PRIOR TO FLUSHING CONTAINED INADEQUATELY FLUSHED MEDICATION OR GLUCOSE FROM PREVIOUS TREATMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL WAS USED AFTER PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND HAD SLIGHT SWELLING TO ANKLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN INFORMED OF THE FOLLOWING ADVERSE EVENT ON 15 JAN 2019 WHEREBY PATIENT CONCERNED REQUESTED NURSING VISITS AS UNABLE TO MANAGE PROCEDURES; THE PATIENT WAS REPORTED TO HAVE BEEN EXPERIENCING SHORTNESS OF BREATH. PATIENT ADVISED ATTENDED LOCAL GP (15 JAN 2019) AND HAD BEEN PRESCRIBED FUROSEMIDE AND A CARDIOLOGY REFERRAL. PATIENT ADVISED HAD SOME SLIGHT SWELLING TO ANKLES; HENCE WENT TO GP. NO FURTHER INFORMATION HAS BEEN OBTAINED ON PATIENTS' OUTCOME FOLLOWING COURSE OF ANTIBIOTIC. PRODUCT: 306572 PFS 0.9%P/FLUSH XS SALINE 10ML ST . BATCH: 8242797 . SAMPLE: NO SAMPLES AVAILABLE . USE: AS DIRECTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL WAS USED AFTER PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND HAD SLIGHT SWELLING TO ANKLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN INFORMED OF THE FOLLOWING ADVERSE EVENT ON (B)(6) 2019 WHEREBY PATIENT CONCERNED REQUESTED NURSING VISITS AS UNABLE TO MANAGE PROCEDURES; THE PATIENT WAS REPORTED TO HAVE BEEN EXPERIENCING SHORTNESS OF BREATH. PATIENT ADVISED ATTENDED LOCAL GP ((B)(6) 2019) AND HAD BEEN PRESCRIBED FUROSEMIDE AND A CARDIOLOGY REFERRAL. PATIENT ADVISED HAD SOME SLIGHT SWELLING TO ANKLES; HENCE WENT TO GP. NO FURTHER INFORMATION HAS BEEN OBTAINED ON PATIENTS' OUTCOME FOLLOWING COURSE OF ANTIBIOTIC. PRODUCT: 306572 PFS 0.9% P/FLUSH XS SALINE 10ML ST; BATCH: 8242797; SAMPLE: NO SAMPLES AVAILABLE; USE: AS DIRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306773 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL SYRINGE NGT BECTON, DICKINSON AND CO. 8242797

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention