BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

    MDR report key: 8324363 · Received February 8, 2019

    Report

    Report Number
    9616657-2019-00118
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    December 14, 2018
    Report Date
    March 15, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    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

    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 (B)(4) 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 WITH THE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH PATIENT APPEARING BREATHLESS WITH SWELLING TO BOTH LEGS.

    Additional Manufacturer Narrative · 1

    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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE THERE WAS AN ISSUE WITH PATIENT APPEARING BREATHLESS WITH SWELLING TO BOTH LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117226 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE FLUSH SYRINGE FMF BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other