BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7469784 · Received April 27, 2018

    Report

    Report Number
    1213809-2018-00268
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    April 6, 2018
    Report Date
    June 29, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097013
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES INCLUDING PHOTOS WERE PROVIDED FOR EVALUATION. HOWEVER THE COMPLAINT IS FOR SHORT COUNT, THEREFORE, IT IS CONFIRMED BASED ON DESCRIPTION. DHR REVIEW FOR BATCH 7240832 (P/N 309701): MANUFACTURING DATES: 09/29/2017 TO 10/01/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7240832 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: MACHINE LOGS REVEAL ISSUES WITH SYRINGE LOADING ROBOT RESULTING IN LOW COUNT TRAYS. THE ISSUE WAS ADDRESSED BEFORE PRODUCTION RESUMED. HOWEVER IT IS POSSIBLE A LIMITED NUMBER OF TRAYS ESCAPED DETECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY THERE WAS AN ISSUE WITH THE STOPPER BEING MISALIGNED. IT WAS STATED ¿SEVERAL OF THE BOXES WITHIN THESE CASES ONLY HAVE 13-19 SYRINGES IN THE PACKAGE VERSUS 25 THAT SHOULD BE IN THE BOX. ADDITIONALLY, THE SYRINGES ARE NOT PROPERLY ALIGNED.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY THERE WAS AN ISSUE WITH THE STOPPER BEING MISALIGNED. IT WAS STATED ¿SEVERAL OF THE BOXES WITHIN THESE CASES ONLY HAVE 13-19 SYRINGES IN THE PACKAGE VERSUS 25 THAT SHOULD BE IN THE BOX. ADDITIONALLY, THE SYRINGES ARE NOT PROPERLY ALIGNED.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313640 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7240832 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other