BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ORAL DISPENSING SYRINGE 10 ML

    MDR report key: 14429780 · Received May 18, 2022

    Report

    Report Number
    1213809-2022-00289
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 16, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILLED. MEDICAL DEVICE EXPIRATION DATE: NA. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 01 APRIL, 2022. MEDWATCH REPORT # MW5108774.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO DISPLAYED A BAG LABELED AS PART NUMBER 305209; HOWEVER, THE BAG WAS OBSERVED TO CONTAIN PART NUMBER 305208. THE OBSERVED MIXED PRODUCT CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS ASSOCIATED WITH INADEQUATE PROCEDURE FOR STAGING THE SUCCEEDING ORDER'S MATERIAL AND OPERATOR FAILURE TO FOLLOW PROCEDURE FOR SCANNING MATERIAL PRIOR TO INTRODUCING TO PRODUCT HOPPER. AS CORRECTIVE ACTIONS, THE MATERIAL HANDLING/LINE CLEARANCE PROCEDURE HAS BEEN UPDATED AND OPERATORS/PERSONNEL POTENTIALLY INVOLVED IN THE MANUFACTURE OF THE BATCH WILL BE RETRAINED TO THE GOODS ISSUE PROCEDURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0272366. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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 PRIOR TO USE THE BD¿ ORAL DISPENSING SYRINGES 10 ML HAD MIXED PRODUCTS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT PRODUCT HAD MIX OF PRODUCT. BD ORAL DISPENSING SYRINGES 10ML AMBER WITH TIP CAP LOT 0272366 HAS BOTH 5ML AND 10ML SYRINGES IN SOME OF THE PACKAGING AND ALL 5ML IN OTHER PACKAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE BD¿ ORAL DISPENSING SYRINGES 10 ML HAD MIXED PRODUCTS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT PRODUCT HAD MIX OF PRODUCT. BD ORAL DISPENSING SYRINGES 10ML AMBER WITH TIP CAP LOT 0272366 HAS BOTH 5ML AND 10ML SYRINGES IN SOME OF THE PACKAGING AND ALL 5ML IN OTHER PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851292 BD¿ ORAL DISPENSING SYRINGE 10 ML LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 0272366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown