BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSIFLUSH

    MDR report key: 17984555 · Received October 23, 2023

    Report

    Report Number
    1911916-2023-00792
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 20, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THE PLUNGER DETACHED FROM STOPPER WHEN ATTEMPTING TO DRAW BLOOD BACK INTO THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING FLOW WRAP OR TIP CAP. A VISUAL INSPECTION WAS PERFORMED. THE PLUNGER ROD IS OUT OF THE SYRINGE BARREL AND IS PARTIALLY ASSEMBLED TO THE RUBBER STOPPER. THE STOPPER AND PLUNGER ROD HAVE SPECIAL DESIGN FEATURES WHICH STOP PULL-BACK ON THE PLUNGER ROD. 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. 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. THE PRODUCT IS NOT DESIGNED TO PULL THE PLUNGER ROD BACK TO DRAW BLOOD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3142743. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT. DEVICE PROBLEM CODE: A0413 - MATERIAL SEPARATION.

    Description of Event or Problem · 0

    (B)(4). NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 306546; LOT #: 3142743. IT WAS REPORTED BY THE CUSTOMER THAT NORMAL SALINE POSI-FLUSH SYRINGE PLUNGER DETACHED FROM STOPPER WHEN ATTEMPTING TO DRAW BLOOD BACK INTO THE SYRINGE. NO BLOOD WAS OBTAINED. NORMAL SALINE POSI-FLUSH SYRINGE PLUNGER DETACHED FROM STOPPER WHEN ATTEMPTING TO DRAW BLOOD BACK INTO THE SYRINGE. NO BLOOD WAS OBTAINED. ADDITIONAL INFORMATION 27OCT2023: THE PRODUCT REF NUMBER IS 306546 THE LOT # 3142743, EXP DATE 2026-05-31.

    Description of Event or Problem · 0

    MATERIAL #: UNKNOWN. LOT #: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT NORMAL SALINE POSI-FLUSH SYRINGE PLUNGER DETACHED FROM STOPPER WHEN ATTEMPTING TO DRAW BLOOD BACK INTO THE SYRINGE. NO BLOOD WAS OBTAINED. VERBATIM: NORMAL SALINE POSI-FLUSH SYRINGE PLUNGER DETACHED FROM STOPPER WHEN ATTEMPTING TO DRAW BLOOD BACK INTO THE SYRINGE. NO BLOOD WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232270 POSIFLUSH SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3142743 30382903065463
    2223322 POSIFLUSH SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 3142743 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown