BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE

    MDR report key: 17795590 · Received September 21, 2023

    Report

    Report Number
    1911916-2023-00679
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 22, 2023
    Report Date
    December 11, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 3103219. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, 132 PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE ALL LOOSELY PACKED IN A BOX WITH THEIR ORIGINAL FLOW WRAP PACKAGING. GLIDE FORCE TESTING WAS PERFORMED ON ALL OF THE RETURNED SAMPLES. OUT OF 132 SAMPLES TESTED, 17 FAILED THE GLIDE FORCE TESTING; CONFIRMING THE REPORTED DEFECT OF PLUNGER MOVEMENT DIFFICULTY DUE TO DRY BARRELS. THE MOST PROBABLE CAUSE FOR THE DEFECTIVE PRODUCT WAS A FAULTY THERMOCOUPLE, WHICH WAS REPLACED EARLIER THIS YEAR. THE THERMOCOUPLE CONTROLS THE DISPERSION OF SILICONE IN THE SYRINGE BARREL. THE FAULTY THERMOCOUPLE IN TURN LED TO INTERMITTENT DEFECTS WHICH WERE NOT DETECTED DURING THE IN-PROCESS CHECKS. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H3. 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 · 0

    RESPONSE RECEIVED ON 30-AUG-2023. WE FIRST HAD AN EVENT ON 8/21. IT WAS DISCOVERED WHILE FLUSHING A PATIENT IV. THERE WAS NO HARM TO THE PATIENT. THIS WAS BEING DONE MANUALLY. THERE WAS NO VISIBLE BLOCKAGE. WE HAD 6 EVENTS TOTAL WITH THE SAME LOT NUMBER. ESSENTIALLY, THE SYRINGES WERE VERY HARD TO FLUSH. YOU HAD TO EXERT AN UNUSUAL AMOUNT OF PRESSURE IN ORDER TO PUSH THE FLUID OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE PLUNGERS ON THE BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE WAS DIFFICULT TO MOVE. THIS IS REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER HAVING TROUBLE PUSHING OUT FLUIDS IN LOT# 3103219 -10 ML PREFILLED SYRINGES. RESPONSE RECEIVED ON 30-AUG-2023. WE FIRST HAD AN EVENT ON (B)(6) 2023. IT WAS DISCOVERED WHILE FLUSHING A PATIENT IV. THERE WAS NO HARM TO THE PATIENT. THIS WAS BEING DONE MANUALLY. THERE WAS NO VISIBLE BLOCKAGE. WE HAD 6 EVENTS TOTAL WITH THE SAME LOT NUMBER. ESSENTIALLY, THE SYRINGES WERE VERY HARD TO FLUSH. YOU HAD TO EXERT AN UNUSUAL AMOUNT OF PRESSURE IN ORDER TO PUSH THE FLUID OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113147 BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 3103219 30382903065463
    64806 BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 3103219 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown