BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL VITAMIN K1 - HEMIN SOLUTION

    MDR report key: 11244892 · Received January 28, 2021

    Report

    Report Number
    1119779-2021-00163
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    December 17, 2020
    Report Date
    June 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 1119779-2021-00163 WAS SENT IN ERROR. THIS COMPLAINT IS NOT MDR REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE. THIS PARTICULAR EVENT WOULD REQUIRE THE USER TO ACQUIRE REPLACEMENT MATERIAL IN ORDER TO USE AS INTENDED. THIS EVENT RESULTS IN USER DISSATISFACTION. THESE PHYSICAL DEFECTS DO NOT NEGATIVELY AFFECT THE RESULTS, AND WOULD RENDER THE PRODUCT UNUSABLE. THIS IS UNLIKELY TO CAUSE SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAMPLE LEAKAGE OCCURRED WITH THE BD BBL¿ VITAMIN K1 - HEMIN SOLUTION PRIOR TO USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT WAS RETURNED. THE OUTER WAS DRY LOOKING BUT WHEN OPENED THE CONTENT WAS SPILLED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SAMPLE LEAKAGE OCCURRED WITH THE BD BBL¿ VITAMIN K1 - HEMIN SOLUTION PRIOR TO USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT WAS RETURNED. THE OUTER WAS DRY LOOKING BUT WHEN OPENED THE CONTENT WAS SPILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141173 BD BBL VITAMIN K1 - HEMIN SOLUTION SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 0295654

    Patients

    Seq Age Sex Outcome Treatment
    1