BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10199652 · Received June 26, 2020

    Report

    Report Number
    9616657-2020-00099
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 30, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/26/2020. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0021182 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETURNED SYRINGE WAS ATTACHED TO A CATHETER AND WAS PLACED WITHIN A BAG. WITHIN THE BAG, THERE WAS LIQUID WHICH LEAKED FROM THE SYRINGE AND CATHETER COMPONENTS. BECAUSE OF THE LEAKAGE DURING TRANSPORT AND/OR STORAGE OF THE SAMPLE, A PROPER EVALUATION OF THE REPORTED EVENT COULD NOT BE COMPLETED AND THE REPORTED COMPLAINT COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% HAD ONLY "HALF" THE AMOUNT OF SODIUM CHLORIDE SOLUTION IN THEM BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PRODUCT ONLY CONTAINS HALF OF THE SODIUM CHLORIDE IN THE SYRINGE"

    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 2 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% HAD ONLY "HALF" THE AMOUNT OF SODIUM CHLORIDE SOLUTION IN THEM BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PRODUCT ONLY CONTAINS HALF OF THE SODIUM CHLORIDE IN THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667951 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 0021182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other