BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ POSIFLUSH¿ SALINE XS 10 ML

    MDR report key: 13473157 · Received February 7, 2022

    Report

    Report Number
    9616657-2022-00003
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 21, 2022
    Report Date
    February 9, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 1203643. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE NOT RETURNED FOR THIS INCIDENT, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED BY OUR QUALITY ENGINEER TEAM. BASED ON THE LIMITED INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ POSIFLUSH¿ SALINE XS 10 ML THE SCALE MARKING WAS MISSING ON TWO SYRINGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: PRODUCT: BD POSIFLUSH XS 10 ML LOT NUMBER: 1203643 PRODUCT EXPIRY DATE: 30-JUN-2024 NUMBER OF DEFECTIVE PRODUCT(S): 2 IS SAMPLE AVAILABLE: YES UNABLE TO VERIFY THAT THE FLUID IN THE SYRINGE MATCHES THE DESCRIPTION ON THE PACKAGE. SYRINGE WAS LACKING ALL APPROPRIATE MARKINGS AND LABELLING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ POSIFLUSH¿ SALINE XS 10 ML THE SCALE MARKING WAS MISSING ON TWO SYRINGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: PRODUCT: BD POSIFLUSH XS 10 ML. LOT NUMBER: 1203643. PRODUCT EXPIRY DATE: 30-JUN-2024. NUMBER OF DEFECTIVE PRODUCT(S): 2. IS SAMPLE AVAILABLE: YES. UNABLE TO VERIFY THAT THE FLUID IN THE SYRINGE MATCHES THE DESCRIPTION ON THE PACKAGE. SYRINGE WAS LACKING ALL APPROPRIATE MARKINGS AND LABELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501471 BD¿ POSIFLUSH¿ SALINE XS 10 ML SALINE, VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 1203643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown