BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ENTERAL SYRINGE

    MDR report key: 17149073 · Received June 16, 2023

    Report

    Report Number
    1911916-2023-00412
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 11, 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

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGES CONTAINED MOISTURE INSIDE THE SYRINGE TIP AND A FEW HAD UNEXPLAINABLE DARK SPOTS INSIDE SEALED PACKAGING OF SYRINGES. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER. THE BOTTOM OF THE SYRINGE BARREL APPEARS TO HAVE THE MEDICAL GRADE LUBRICANT THAT IS APPLIED TO THE INNER WALL OF THE SYRINGE BARREL AND RUBBER STOPPER DURING MANUFACTURING. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305864, POSSIBLE LOT NUMBERS 2243929 AND 2243934. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 BD¿ ENTERAL SYRINGE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THROUGH INSPECTION PRIOR TO USE MULTIPLE LOTS OF MED-RX BD STERILE SYRINGES FOR ORAL/ENTERAL MOSTLY CONTAINED MOISTURE INSIDE SYRINGE TIP AND/OR BARREL, AND FEW HAD UNEXPLAINABLE DARK SPOTS INSIDE SEALED PACKAGING OF SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ ENTERAL SYRINGE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THROUGH INSPECTION PRIOR TO USE MULTIPLE LOTS OF MED-RX BD STERILE SYRINGES FOR ORAL/ENTERAL MOSTLY CONTAINED MOISTURE INSIDE SYRINGE TIP AND/OR BARREL, AND FEW HAD UNEXPLAINABLE DARK SPOTS INSIDE SEALED PACKAGING OF SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679646 BD¿ ENTERAL SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243929

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown