BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE

    MDR report key: 17815784 · Received September 26, 2023

    Report

    Report Number
    1911916-2023-00686
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 8, 2023
    Report Date
    September 26, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 18-SEP-2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE PLUNGER IS DIFFICULT TO MOVE. TO AID IN THE INVESTIGATION, TWO EMPTY SAMPLES WITH NO PACKAGING FLOW WRAP, OR TIP CAP, AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND ALL RESULTS WERE WITHIN SPECIFICATION. THE PHOTO PROVIDED SHOWS ONE OF THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3090870. 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 COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT THE PLUNGER ON THE BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE WAS DIFFICULT TO MOVE. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PHARMACIST CALLED TO REPORT THAT THERE HAVE BEEN 2 OCCURRENCES OF THE PLUNGER BEING DIFFICULT TO MOVE. 1ST ON (B)(6) 2023 (LOT# 3090870) AND AGAIN ON (B)(6) 2023 (LOT# 3090870). THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER ON THE BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE WAS DIFFICULT TO MOVE. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PHARMACIST CALLED TO REPORT THAT THERE HAVE BEEN 2 OCCURRENCES OF THE PLUNGER BEING DIFFICULT TO MOVE. 1ST ON (B)(6) 2023 (LOT# 3090870) AND AGAIN ON (B)(6) 2023 (LOT# 3090870). THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440577 BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 3090870 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown