BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 17831028 · Received September 28, 2023

    Report

    Report Number
    1911916-2023-00692
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 8, 2023
    Report Date
    November 6, 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
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE PLUNGER IS NOT WORKING PROPERLY. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS THREE EMPTY SYRINGES WITH THE SYRINGE BARREL LABEL THAT CONFIRMS THE LOT NUMBER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3142760. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    H.3. 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

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 306546 BATCH#: 3142760 IT WAS REPORTED BY THE CUSTOMER THAT PLUNGER NOT WORKING APPROPRIATELY. TO INITIALLY USE THEM AND GET THE AIR OUT, YOU CAN NOT PULL BACKWARDS AND ONLY PUSH FORWARD VERY FORCEFULLY TO GET IT TO CLICK AND THEN WORK. WHEN BEING PLACED ON THE SYRINGE PUMPS TO FLUSH, THEY WORK FOR A LITTLE BIT AND THEN GET STUCK AGAIN AND HAVE TO BE RE POPPED TO GET THEM MOVING AGAIN BUT FORCEFULLY PULLING BACK. CUSTOMER HAD 3 SITTING ON HIS DESK EMPTY TO SHOW THE PROBLEM AND OVERNIGHT THEY GOT STUCK AGAIN AND HAD TO FORCEFULLY PULL BACKWARDS AND HEARD THE PLUNGER POP TO GET IT TO WORK AGAIN. VERBATIM: PRODUCT PART # 306546 DESCRIPTION SALINE SYRINGE 10ML PRE-FILLED ISSUE PLUNGER NOT WORKING APPROPRIATELY. TO INITIALLY USE THEM AND GET THE AIR OUT, YOU CAN NOT PULL BACKWARDS AND ONLY PUSH FORWARD VERY FORCEFULLY TO GET IT TO CLICK AND THEN WORK. WHEN BEING PLACED ON THE SYRINGE PUMPS TO FLUSH, THEY WORK FOR A LITTLE BIT AND THEN GET STUCK AGAIN AND HAVE TO BE RE POPPED TO GET THEM MOVING AGAIN BUT FORCEFULLY PULLING BACK. I HAD 3 SITTING ON MY DESK EMPTY TO SHOW THE PROBLEM AND OVERNIGHT THEY GOT STUCK AGAIN AND HAD TO FORCEFULLY PULL BACKWARDS AND HEARD THE PLUNGER POP TO GET IT TO WORK AGAIN. RESPONSE RECEIVED ON (B)(6)2023. ALL 3 INSTANCES WERE ON DIFFERENT PATIENTS. THERE WERE MORE THAN 3 INSTANCES PRIOR TO BEING NOTIFIED OF THE ISSUE AND ONCE IT WAS IDENTIFIED, WE REMOVED THAT LOT NUMBER AND HAVEN¿T HAD ANY ISSUES SINCE. THE DEVICE WAS BEING USED BOTH ON PUMP AND MANUALLY. WHEN THE PUMP WOULD ALARM, WE WOULD TRY TO FLUSH BY HAND AND IT DID NOT MOVE AND WERE UNABLE TO MANUALLY MANIPULATE THE SYRINGE WITHOUT EXTREME PRESSURE BEING APPLIED AND RE BREAKING THE SEAL. THESE SYRINGES WERE THE PREFILLED NORMAL SALINE SYRINGES I HAVE ATTACHED A PICTURE OF THE 3 SYRINGES THAT I WAS ABLE TO GET A HANDLE ON. IT DOES NOT SHOW THE ISSUE BUT SHOWS THE SAME LOT # AND ALL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WAS DIFFICULT TO PUSH DURING USE AND GOT STUCK. REPORT 1 OF 3. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER NOT WORKING APPROPRIATELY. TO INITIALLY USE THEM AND GET THE AIR OUT, YOU CAN NOT PULL BACKWARDS AND ONLY PUSH FORWARD VERY FORCEFULLY TO GET IT TO CLICK AND THEN WORK. WHEN BEING PLACED ON THE SYRINGE PUMPS TO FLUSH, THEY WORK FOR A LITTLE BIT AND THEN GET STUCK AGAIN AND HAVE TO BE RE POPPED TO GET THEM MOVING AGAIN BUT FORCEFULLY PULLING BACK. I HAD 3 SITTING ON MY DESK EMPTY TO SHOW THE PROBLEM AND OVERNIGHT THEY GOT STUCK AGAIN AND HAD TO FORECULLY PULL BACKWARDS AND HEARD THE PLUNGER POP TO GET IT TO WORK AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155501 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 3142760 30382903065463
    1247962 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 3142760 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown