BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9616657-2019-00155

    MDR report key: 8436697 · Received March 20, 2019

    Report

    Report Number
    9616657-2019-00155
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    January 9, 2019
    Report Date
    April 17, 2019
    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 THESE BATCHES, AND THERE WAS NO RECORD OF NON-CONFORMANCE WHICH COULD CONTRIBUTE TO THE COMPLAINT VERBATIM REPORTED BY THE CUSTOMER. 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 AFTER USING BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE, PATIENT EXPERIENCED SYMPTOMS OF NAUSEA, SLIGHT INCREASE IN BODY TEMPERATURE. THERE WAS UNKNOWN CAUSE OF PYREXIA. PATIENT WAS ADVICE TO GO TO HOSPITAL. CUSTOMER¿S VERBATIM: ¿ WE HAVE RECEIVED AN ADVERSE EVENT REPORT ON (B)(6) 2019 CONCERNING THE AFOREMENTIONED PRODUCT, WHEREBY PATIENT EXPERIENCED SYMPTOMS OF NAUSEA AND SLIGHT INCREASE IN BODY TEMPERATURE - NO KNOWN CAUSE FOR PYREXIA. PATIENT ADVISED TO ATTEND HOSPITAL; NO FURTHER INFORMATION HAS BEEN OBTAINED IN REGARDS TO PATIENT OUTCOME FOLLOWING A& E VISIT. PRODUCT - 306572 PFS 0.9% P/FLUSH XS SALINE . BATCH - 8242797 / 8270683 . SAMPLES: NO USE: 10 ML TO FLUSH LINE BEFORE AND 20 ML AFTER EACH INFUSION AS DIRECTED.¿

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8242797. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2018-08-30. MEDICAL DEVICE LOT #: 8270683. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2018-09-27. (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 AFTER USING BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE, PATIENT EXPERIENCED SYMPTOMS OF NAUSEA, SLIGHT INCREASE IN BODY TEMPERATURE. THERE WAS UNKNOWN CAUSE OF PYREXIA. PATIENT WAS ADVICE TO GO TO HOSPITAL. CUSTOMER¿S VERBATIM: ¿ WE HAVE RECEIVED AN ADVERSE EVENT REPORT ON (B)(6) 2019 CONCERNING THE AFOREMENTIONED PRODUCT, WHEREBY PATIENT EXPERIENCED SYMPTOMS OF NAUSEA AND SLIGHT INCREASE IN BODY TEMPERATURE - NO KNOWN CAUSE FOR PYREXIA. PATIENT ADVISED TO ATTEND HOSPITAL; NO FURTHER INFORMATION HAS BEEN OBTAINED IN REGARDS TO PATIENT OUTCOME FOLLOWING A& E VISIT. PRODUCT - 306572 PFS 0.9% P/FLUSH XS SALINE. BATCH - 8242797 / 8270683. SAMPLES: NO USE: 10 ML TO FLUSH LINE BEFORE AND 20 ML AFTER EACH INFUSION AS DIRECTED.¿

    Patients

    Seq Age Sex Outcome Treatment
    1 Other