BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH IV FLUSH NORMAL SALINE FILLED SYRINGE

    MDR report key: 16966289 · Received May 19, 2023

    Report

    Report Number
    1911916-2023-00328
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 26, 2023
    Report Date
    May 1, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. LOT NUMBER WAS NOT REPORTED; HOWEVER, A POTENTIAL LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THAT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2340250. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2025. DEVICE MANUFACTURE DATE: 06-DEC-2022. MEDICAL DEVICE LOT #: 3031739. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. DEVICE MANUFACTURE DATE: 31-JAN-2023.. MEDICAL DEVICE LOT #: 2297879. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2025. DEVICE MANUFACTURE DATE: 24-OCT-2022. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS AN INFECTION AT THE IV INSERTION AREA. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, POSSIBLE LOT NUMBERS 2340250, 3031739 AND 2297879. 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 LOT. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT REPORTED AN INFECTION WHILE USING BD POSIFLUSH IV FLUSH NORMAL SALINE FILLED SYRINGE. THIS IS THE 1ST OF 3 PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CONCERN PER CUSTOMER-I WAS NOTIFIED THAT 3 PATIENTS FROM LAST WEEK REPORTED AN INFECTION IN THE IV INSERTION SITE AREA. WE EXCLUDED SEVERAL FACTORS AND LEFT A FEW BY IDENTIFYING THE COMMON DENOMINATOR, SALINE BEING ONE OF THE COMMON DENOMINATORS. THIS MORNING AN IV WAS PLACED AND AS SOON AS THE NORMAL SALINE WAS INJECTED, PT EXPRESSED PAIN AND HAD A HARD BUMP, AND THE AREA STARTED SWELLING UP. MAKING ME BELIEVE IT WAS THE SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622743 BD POSIFLUSH IV FLUSH NORMAL SALINE FILLED SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other