BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 14415244 · Received May 17, 2022

    Report

    Report Number
    3002682307-2022-00141
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    April 26, 2022
    Report Date
    July 11, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUTION: YES. D9: RETURNED TO MANUFACTURER ON: 15-JUN-2022 H6: INVESTIGATION SUMMARY TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLE APPEARS TO HAVE BEEN USED AND THE STOPPER WAS LOCATED AT THE 5ML MARKING. A SILICONE DISTRIBUTION TEST WAS PERFORMED ON THE RETURNED SAMPLE. THE TEST RESULTS SHOWED A PARTIAL LACK OF SILICONE, CONFIRMING THE REPORTED DEFECT OF PLUNGER MOVEMENT DIFFICULTY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575 AND LOT NUMBER 2033252. THERE WERE NO QUALITY NOTIFICATIONS ISSUED DURING THE PRODUCTION PROCESS; HOWEVER, TWO SECOND SAMPLINGS FOR DRY BARRELS WERE PERFORMED. THE MACHINERY WAS CHECKED AFTER EACH SAMPLING AND THE SILICONE VALVE GATE WAS FOUND TO BE THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE BLOCKS AT ABOUT 5.5 ML, IS THEN STUCK AND DOES NOT WANT TO CONTINUE".

    Description of Event or Problem · 0

    IT WAS REPORTED BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE BLOCKS AT ABOUT 5.5 ML, IS THEN STUCK AND DOES NOT WANT TO CONTINUE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396369 BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 2033252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown