BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10482506 · Received September 2, 2020

    Report

    Report Number
    9616657-2020-00135
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0111366 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, THE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETURNED SAMPLE WAS EXAMINED AND THE PLUNGER WAS PRESSED DOWNWARDS. NO SIGNS OF PLUNGER MOVEMENT DIFFICULTY WERE DETECTED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DISCONNECTING THE SYRINGE FROM THE LINE AND ATTEMPTING TO FLUSH THE STOPPER WAS JAMMED WITH A BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT¿S DAUGHTER REPORTS THAT SHE HAD A FAULTY POSIFLUSH WHEN DISCONNECTING THE PATIENT FROM THEIR PN INFUSION. THE FLUSH WOULD NOT INFUSE, AND THE DAUGHTER THOUGHT THE LINE WAS BLOCKED DUE TO THE RESISTANCE. WHEN THE DAUGHTER REMOVED SYRINGE FROM THE LINE SHE ATTEMPTED TO FLUSH BUT THE BLACK PLUNGER WAS STUCK WITHIN THE SYRINGE. DAUGHTER SAID SHE WILL USE ANOTHER POSIFLUSH TO ENSURE PATENCY OF THE LINE. HALF OF THE ORIGINAL POSIFLUSH USED SO WILL ONLY USE HALF OF THE NEXT AS PER PRESCRIPTION.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN DISCONNECTING THE SYRINGE FROM THE LINE AND ATTEMPTING TO FLUSH THE STOPPER WAS JAMMED WITH A BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT¿S DAUGHTER REPORTS THAT SHE HAD A FAULTY POSIFLUSH WHEN DISCONNECTING THE PATIENT FROM THEIR PN INFUSION. THE FLUSH WOULD NOT INFUSE, AND THE DAUGHTER THOUGHT THE LINE WAS BLOCKED DUE TO THE RESISTANCE. WHEN THE DAUGHTER REMOVED SYRINGE FROM THE LINE SHE ATTEMPTED TO FLUSH BUT THE BLACK PLUNGER WAS STUCK WITHIN THE SYRINGE. DAUGHTER SAID SHE WILL USE ANOTHER POSIFLUSH TO ENSURE PATENCY OF THE LINE. HALF OF THE ORIGINAL POSIFLUSH USED SO WILL ONLY USE HALF OF THE NEXT AS PER PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950039 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 0111366

    Patients

    Seq Age Sex Outcome Treatment
    1 Other