BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    MDR report key: 17645090 · Received August 29, 2023

    Report

    Report Number
    1911916-2023-00620
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 6, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 05-SEP-2023. H6: INVESTIGATION SUMMARY : IT WAS REPORTED THE PLUNGER IS STOPPING MID FLUSH. TO AID IN THE INVESTIGATION, ONE EMPTY SAMPLE 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. THE SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE PER IT287, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND THE RESULT WAS WITHIN SPECIFICATION. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3142731. 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 OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES, THE PLUNGER WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DETAILS: NORMAL SALINE SYRINGES OF 0.9% LOT # 3142731 HAS BEEN STOPPING ABOUT 2/3RD MID FLUSH. NOTED WITH 2 SYRINGES IN THE SAME LOT NUMBER SO FAR. FREQUENCY OF PROBLEM: FIRST TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES, THE PLUNGER WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DETAILS: NORMAL SALINE SYRINGES OF 0.9% LOT # 3142731 HAS BEEN STOPPING ABOUT 2/3RD MID FLUSH. NOTED WITH 2 SYRINGES IN THE SAME LOT NUMBER SO FAR. FREQUENCY OF PROBLEM: FIRST TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086020 BD POSIFLUSH¿ NORMAL SALINE SYRINGES, SALINE, VASCULAR ACCESS FLUSH FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 3142731 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown