BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ENTERAL SYRINGE

    MDR report key: 17012734 · Received May 26, 2023

    Report

    Report Number
    1911916-2023-00349
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    May 4, 2023
    Report Date
    May 9, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN 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

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT TWO CONTAMINATED 30ML STERILE SYRINGES WERE DISCOVERED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE BARREL WITH A BROWN SPOT AT THE 36ML MARK IN THE GRADUATION SCALE. THE SPOT APPEARS TO BE EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305964, LOT 2243929. 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ ENTERAL SYRINGE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUANTITY 2 EACH AS PER COMPLAINT DESCRIPTION COMPLAINT DESCRIPTION TWO CONTAMINATED 30ML STERILE SYRINGES WERE DISCOVERED TODAY DURING BREAST MILK PREPARATION. BOTH CONTAINED MULTIPLE SPOTS OF BROWN SUBSTANCE MIXED WITHIN THE PLASTIC OF SYRINGE. ONE OF THE TWO 30ML SYRINGES DID NOT COME IN ANY CONTACT WITH PATIENT MILK. UNFORTUNATELY, THE OTHER SYRINGE DID COME IN CONTACT WITH BREAST MILK FOR PATIENT'S BABY A AND BABY B, AND 24ML OF EBM WAS DISCARDED IN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718196 BD¿ ENTERAL SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243929

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown