BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRE-FILLED SALINE SYRINGE

    MDR report key: 17646473 · Received August 29, 2023

    Report

    Report Number
    1911916-2023-00621
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 11, 2023
    Report Date
    August 29, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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: 25AUG2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A BLACK SUBSTANCE INSIDE AND NEAR THE WHITE CONE HEAD CAP. TO AID IN THE INVESTIGATION, ONE EMPTY SAMPLE WITH AN OPENED PACKAGING FLOW WRAP WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE TIP CAP HAS EMBEDDED DISCOLORATION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS CONTAMINATION FROM THE RESIN OR COLORANT THAT BECAME MOLDED INTO THE CAP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306593, LOT 2153613. 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. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. 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 IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRE-FILLED SALINE SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE CUSTOMER GOT THIS PRECHARGED WITHOUT REMOVING THE OUTER PACKAGE, HE FOUND BLACK SUBSTANCE INSIDE AND NEAR THE WHITE CONE HEAD CAP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRE-FILLED SALINE SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE CUSTOMER GOT THIS PRECHARGED WITHOUT REMOVING THE OUTER PACKAGE, HE FOUND BLACK SUBSTANCE INSIDE AND NEAR THE WHITE CONE HEAD CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729860 BD PRE-FILLED SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 2153613

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown