BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

    MDR report key: 8329588 · Received February 11, 2019

    Report

    Report Number
    9616657-2019-00121
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    December 16, 2018
    Report Date
    March 15, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    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

    INVESTIGATION SUMMARY: DHR: 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. CONCLUSION(S): 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 THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE CAUSED AN UNSPECIFIED NUMBER OF ALLERGIC REACTIONS WHICH INCLUDED BREATHLESSNESS AND SWELLING TO BOTH LEGS.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8179538. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30. DEVICE MANUFACTURE DATE: 2018-06-28. MEDICAL DEVICE LOT #: 8185572. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30. DEVICE MANUFACTURE DATE: 2018-07-04. MEDICAL DEVICE LOT #: 8242797. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2018-08-30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE CAUSED AN UNSPECIFIED NUMBER OF ALLERGIC REACTIONS WHICH INCLUDED BREATHLESSNESS AND SWELLING TO BOTH LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118071 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE SYRINGE FMF BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other