BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ POSIFLUSH¿ SALINE XS 10 ML

    MDR report key: 15789774 · Received November 14, 2022

    Report

    Report Number
    9616657-2022-00038
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE POTENTIALLY INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9232938; MEDICAL DEVICE EXPIRATION DATE: 31JUL2022; DEVICE MANUFACTURE DATE: 20AUG2019; MEDICAL DEVICE LOT #: 9235407; MEDICAL DEVICE EXPIRATION DATE: 31JUL2022; DEVICE MANUFACTURE DATE: 23AUG2019; MEDICAL DEVICE LOT #: 9182101; MEDICAL DEVICE EXPIRATION DATE: 30JUN2022; DEVICE MANUFACTURE DATE: 01JUL2019; MEDICAL DEVICE LOT #: 9248167; MEDICAL DEVICE EXPIRATION DATE: 31AUG2022; DEVICE MANUFACTURE DATE: 05SEP2019. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND POTENTIAL LOT NUMBERS 9224747, 9232938, 9235407, 9182101, AND 9248167. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ALL RELEVANT IN PROCESS AND FINISHED PRODUCT INSPECTIONS PERFORMED WERE FOUND TO BE WITHIN SPECIFICATION. THE TEST RESULTS ENSURED THAT THE PRODUCTS WERE FIT FOR THEIR INTENDED USE AND MET THE STANDARD REQUIREMENTS FOR THE PRODUCT, AS VERIFIED BY THE FACILITY MICROBIOLOGIST¿S EVALUATION. THE LOTS PROVIDED WERE MANUFACTURED IN 2019. PLEASE NOTE THAT BD POSIFLUSH HAS AN EXPIRY DATE OR 2 YEARS AND 11 MONTHS FROM THE DATE OF MANUFACTURING. AS SAMPLES WERE UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ POSIFLUSH¿ SALINE XS 10 ML AN INFECTION OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT IN RELATION TO PRODUCT BD306572 LOT NUMBERS 9224747, 9232938, 9235407, 9182101, 9248167. THE CUSTOMER STATES THAT THEIR DAUGHTER EXPERIENCED A LINE INFECTION AFTER USING THE PRODUCT, THEY ARE UNSURE WHICH LOT NUMBER IT BELONGS TO BUT HAVE ADVISED OF ALL THE LOT NUMBERS THEY HAD AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350344 BD¿ POSIFLUSH¿ SALINE XS 10 ML SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 9224747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other