BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ORAL DISPENSING SYRINGE

    MDR report key: 10743588 · Received October 27, 2020

    Report

    Report Number
    1213809-2020-00749
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    August 18, 2020
    Report Date
    November 16, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2020-10-26 H6: INVESTIGATION SUMMARY ONE PHOTO AND ONE 3ML ORAL AMBER SYRINGE WERE RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. THE PLUNGER ROD WAS OBSERVED TO HAVE ONE CRACKED RIB, WHICH IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0060391 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ ORAL DISPENSING SYRINGE PLUNGER WAS FOUND CRACKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOLLOWING QUALITY INSPECTION ON THIS BATCH THERE HAS BEEN 1 CRITICAL DEFECT FOUND WITHIN THE 800 SAMPLES TAKEN. THE SYRINGE FAILED DUE TO A CRACKED PLUNGER"

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ ORAL DISPENSING SYRINGE PLUNGER WAS FOUND CRACKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOLLOWING QUALITY INSPECTION ON THIS BATCH THERE HAS BEEN 1 CRITICAL DEFECT FOUND WITHIN THE 800 SAMPLES TAKEN. THE SYRINGE FAILED DUE TO A CRACKED PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209564 BD ORAL DISPENSING SYRINGE LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 0060391

    Patients

    Seq Age Sex Outcome Treatment
    1