BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ CONTROL SYRINGE STERILE, SINGLE USE, 10 ML

    MDR report key: 13588688 · Received February 23, 2022

    Report

    Report Number
    1213809-2022-00098
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 24, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-03-10. INVESTIGATION SUMMARY: ONE 10ML LUER-LOCK CONTROL SYRINGE WAS RECEIVED AND EVALUATED. THE FINGER GRIP IS BROKEN IN HALF TOWARDS THE MIDDLE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BROKEN FINGER GRIP DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 1111319 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 WHILE USING A BD LUER-LOK¿ CONTROL SYRINGE STERILE, SINGLE USE, 10 ML, THE SYRINGE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE BROKE IN HALF WHILE INJECTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD LUER-LOK¿ CONTROL SYRINGE STERILE, SINGLE USE, 10 ML, THE SYRINGE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE BROKE IN HALF WHILE INJECTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225243 BD LUER-LOK¿ CONTROL SYRINGE STERILE, SINGLE USE, 10 ML PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309695 1111319 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown