BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ENTERAL SYRINGE

    MDR report key: 16705165 · Received April 8, 2023

    Report

    Report Number
    1911916-2023-00221
    Event Type
    Malfunction
    Date Received
    April 8, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 23, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 22-MAY-2023. H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A CRACK IN THE PLASTIC OF THE SYRINGE BARREL. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL HAS A CRACK THAT IS ABOUT 1" LONG. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND THE PLUNGER ROD ALL THE WAY DOWN. THERE IS WHAT APPEARS TO BE A CRACK THAT STARTS AT THE BOTTOM OF THE SYRINGE BARREL UP TO THE 4ML OF THE GRADUATION SCALE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE SAMPLE JAMMED IN ONE OF THE CONVEYORS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305860, LOT 2210980. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY - IT WAS REPORTED THERE WAS A CRACK IN THE PLASTIC OF THE SYRINGE BARREL. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER AND THE PLUNGER ROD ALL THE WAY DOWN. THERE IS WHAT APPEARS TO BE A CRACK THAT STARTS AT THE BOTTOM OF THE SYRINGE BARREL UP TO THE 4ML OF THE GRADUATION SCALE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305860, LOT 2210980. 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. 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 BD¿ ENTERAL SYRINGE PLASTIC WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACK IN PLASTIC OF SYRINGE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ ENTERAL SYRINGE PLASTIC WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRACK IN PLASTIC OF SYRINGE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752930 BD¿ ENTERAL SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2210980

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown