BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    MDR report key: 17607421 · Received August 23, 2023

    Report

    Report Number
    1911916-2023-00607
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 7, 2023
    Report Date
    July 26, 2024
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED SOME OF THE FLUSHES ARE HARD TO PUSH OR FLUSH. TO AID IN THE INVESTIGATION, FOUR EMPTY SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO SAMPLES WERE FROM LOT 3142676, ONE SAMPLE WAS FROM 3016502, AND ONE SAMPLE WAS FROM LOT 3142665. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH 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 ALL RESULTS WERE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOTS 3142676, 3016502 AND 3142665. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS 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 THESE LOTS. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3142676. D4. MEDICAL DEVICE EXPIRATION DATE: 30APR2026. H4. DEVICE MANUFACTURE DATE: 22MAY2023. D4. MEDICAL DEVICE LOT #: 3016502. D4. MEDICAL DEVICE EXPIRATION DATE: 31JAN2026. H4. DEVICE MANUFACTURE DATE: 16JAN2023. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    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: I RECEIVED COMPLAINTS FROM OUR ED DEPARTMENT THAT SOME OF OUR FLUSHES ARE HARD TO PUSH/FLUSH. THEY PROVIDED ME THE 2 LOT #S THAT THEY ARE HAVING ISSUES. LOT # 3142676, LOT# 3016502.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497823 BD POSIFLUSH¿ NORMAL SALINE SYRINGES, SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 3142665 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown