BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, IRRIGATING (NON DENTAL)

    MDR report key: 20144629 · Received September 5, 2024

    Report

    Report Number
    2618282-2024-00120
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 24, 2024
    Report Date
    November 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    KYW
    UDI-DI
    50382904085310
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED IN THE PHOTO A WHITE FEMALE CAP IN AN OPEN BLISTER AND IN THE TOP PART A DARK MARK IS SEEN; IN THE 2ND PHOTO A DARK MARK IS SEEN INSIDE THE CAP. ADDITIONALLY, ONE SAMPLE RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, FOREIGN MATTER CAN BE OBSERVED, ADDITIONAL TESTING WAS PERFORMED, FOREIGN SUBSTANCE IS LIKELY CARDBOARD, OR PAPER. 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. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH OPERATOR ERROR DURING THE MANUAL LOAD AND FED OF PRODUCT INTO THE BLISTER POCKET FOREIGN MATTER. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. 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.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED IN THE PHOTO A WHITE FEMALE CAP IN AN OPEN BLISTER AND IN THE TOP PART A DARK MARK IS SEEN; IN THE 2ND PHOTO A DARK MARK IS SEEN INSIDE THE CAP. 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. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH OPERATOR ERROR DURING THE MANUAL LOAD AND FED OF PRODUCT INTO THE BLISTER POCKET FOREIGN MATTER. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL#: 408531; BATCH#: 2222712. VERBATIM: BLACK PARTICLE. ADDITIONAL INFORMATION: DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? IT WAS FOUND DURING PRODUCT PROCESSING, BUT PRIOR TO USING THE CAP (FOUND DURING INSPECTION OF THE SUPPLY). 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268707 SYRINGE, IRRIGATING (NON DENTAL) SYRINGE, PISTON KYW BECTON DICKINSON 2222712 50382904085310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown