BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8827566 · Received July 25, 2019

    Report

    Report Number
    9616657-2019-00272
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER WAS UNABLE TO VERIFY THE REPORTED COMPLAINT. PHOTOS OR SAMPLES ARE NOT AVAILABLE FOR ANALYSIS AND BECAUSE NO OBJECTIVE EVIDENCE OF THIS ISSUE WAS FOUND DURING THE ANALYSIS OF THE DEVICE HISTORY RECORD FOR THE CLAIMED LOT, IT WAS NOT POSSIBLE TO VERIFY THIS COMPLAINT AS BEING GENERATED BY MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD POSIFLUSH¿ NORMAL SALINE SYRINGES "SQUIRTED" SALINE SOLUTION ONTO THE STAFF DURING USE WHILE FLUSHING THEIR IV LINES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRE-FILLED FLUSH SYRINGE "SQUIRTED" FLUID BACK ONTO STAFF WHEN IV FLUSHED. NO HAZARDOUS DRUG EXPOSURE OCCURRED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K161552 ((B)(4)), PMA / 510(K)#: K141311 ((B)(4)). 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 5 BD POSIFLUSH¿ NORMAL SALINE SYRINGES "SQUIRTED" SALINE SOLUTION ONTO THE STAFF DURING USE WHILE FLUSHING THEIR IV LINES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRE-FILLED FLUSH SYRINGE "SQUIRTED" FLUID BACK ONTO STAFF WHEN IV FLUSHED. NO HAZARDOUS DRUG EXPOSURE OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623190 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 9065683 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other