BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 19169985 · Received April 24, 2024

    Report

    Report Number
    1911916-2024-00279
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THE PLUNGER ROD DISCONNECTS FROM THE STOPPER AND POPS OUT. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS AN EMPTY PREFILLED SYRINGE WITH THE PLUNGER ROD REMOVED. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. THIS PRODUCT IS DESIGNED TO PUSH DOWN THE SYRINGE PLUNGER ROD-RUBBER STOPPER WHILE EXPELLING THE SALINE SOLUTION. AFTER, THE PRODUCT SHOULD BE DISCARDED. THE FLUSH IS NOT DESIGNED TO PULL THE PLUNGER ROD-RUBBER STOPPER BACK. THE STOPPER AND PLUNGER ROD HAVE SPECIAL DESIGN FEATURE WHICH STOPS PULL-BACK ON THE PLUNGER ROD. PULLING BACK ON THE PLUNGER ROD, EITHER BEFORE, DURING OR AFTER THE ADMINISTRATION OF SALINE FLUSH MAY LEAD TO PLUNGER ROD BEING SEPARATED FROM THE STOPPER, ESPECIALLY WHEN THE PLUNGER ROD IS TWISTED DURING PULL-BACK MOTION. THIS SAFETY MECHANISM PREVENTS THE SOLUTION FROM ENTERING A NON-STERILE AREA OF THE SYRINGE, HELPING TO REDUCE THE RISK OF SOLUTION CONTAMINATION AND THEREBY ENSURING PATIENT SAFETY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT 4003449. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 306547. LOT # 4003449. IT WAS REPORTED BY CUSTOMER THAT WHEN USING THE BD POSIFLUSH 10ML SALINE FLUSH, THEY ARE ABLE TO EASILY FLUSH SALINE INTO THE IV BUT WHEN THEY PULL BACK TO CHECK FOR BLOOD RETURN (FREQUENT PRACTICE IN CHEMO SUITE), THE PLUNGER ROD DISCONNECT FROM THE STOPPER AND POPS OUT. VERBATIM: SEVERAL NURSES HAVE REPORTED THAT WHEN USING THE BD POSIFLUSH 10ML SALINE FLUSH, THEY ARE ABLE TO EASILY FLUSH SALINE INTO THE IV BUT WHEN THEY PULL BACK TO CHECK FOR BLOOD RETURN (FREQUENT PRACTICE IN CHEMO SUITE), THE PLUNGER ROD DISCONNECT FROM THE STOPPER AND POPS OUT. THEY ARE ABLE TO SCREW IT BACK IN BUT THEY FEEL IT WASN'T SECURE TO BEGIN WITH. THIS POSES A SAFETY HAZARD AS THEY ARE CONNECTED TO THE PATIENT'S IV ACCESS AND (POTENTIALLY) BLOOD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 306547. LOT # 4003449. IT WAS REPORTED BY CUSTOMER THAT WHEN USING THE BD POSIFLUSH 10ML SALINE FLUSH, THEY ARE ABLE TO EASILY FLUSH SALINE INTO THE IV BUT WHEN THEY PULL BACK TO CHECK FOR BLOOD RETURN (FREQUENT PRACTICE IN CHEMO SUITE), THE PLUNGER ROD DISCONNECT FROM THE STOPPER AND POPS OUT. VERBATIM: SEVERAL NURSES HAVE REPORTED THAT WHEN USING THE BD POSIFLUSH 10ML SALINE FLUSH, THEY ARE ABLE TO EASILY FLUSH SALINE INTO THE IV BUT WHEN THEY PULL BACK TO CHECK FOR BLOOD RETURN (FREQUENT PRACTICE IN CHEMO SUITE), THE PLUNGER ROD DISCONNECT FROM THE STOPPER AND POPS OUT. THEY ARE ABLE TO SCREW IT BACK IN BUT THEY FEEL IT WASN'T SECURE TO BEGIN WITH. THIS POSES A SAFETY HAZARD AS THEY ARE CONNECTED TO THE PATIENT'S IV ACCESS AND (POTENTIALLY) BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381922 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 4003449 30382903065470
    157877 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 4003449 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown