BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML SYRINGE 22G X 1 RP

    MDR report key: 16000232 · Received December 16, 2022

    Report

    Report Number
    1017768-2022-01039
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Report Date
    January 10, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMF
    UDI-DI
    10884521012714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, THE SAMPLES WILL BE INSPECTED FOR LEAKS AND VERIFY THE LOT NUMBER/PRINT ON THE BOXES, IF REQUIRED. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. PHOTOS OF THE CARTON AND ONE UNUSED, OPENED DEVICE WAS RETURNED FOR EVALUATION. A FUNCTIONAL TEST WAS PERFORMED ON THE SYRINGE; THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THERE WERE NO ANOMALIES FOUND DURING A REVIEW OF THE DHR, MAINTENANCE RECORDS OR PROCESS MONITORING DATA. THERE WAS NO EVIDENCE OF ANY SYSTEMIC FAILURE OF THE MANUFACTURING PROCESS. ALSO, THERE WAS NO TREND OBSERVED. THE PHOTOS OF THE CARTON WERE ALSO REVIEWED FOR THE REPORTED ISSUE OF MISSING EXPIRATION DATE. HOWEVER, THE REPORTED PRODUCT DOES NOT HAVE AN EXPIRATION DATE, HENCE IS NOT PRINTED. BASED ON THE INVESTIGATION AND ROOT CAUSE ANALYSIS, THE INITIATION OF A CORRECTIVE AND PREVENTION ACTION IS NOT REQUIRED AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ABOUT 1/3 OF THE BOX IS LEAKING THROUGH THE PLUNGER. THE PRODUCT WAS USED IN A VETERINARY SETTING. ADDITIONAL INFORMATION STATED THAT THE SYRINGE DOESN'T APPEAR TO HAVE ANY PROBLEMS. THE PLUNGER IS SEATED CORRECTLY. THE CUSTOMER ALSO STATED THERE IS NOT AN EXPIRATION DATE ON THE CARTON.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ABOUT 1/3 OF THE BOX IS LEAKING THROUGH THE PLUNGER. THE PRODUCT WAS USED IN A VETERINARY SETTING. ADDITIONAL INFORMATION PROVIDED STATED THAT THE SYRINGE DOESN'T APPEAR TO HAVE ANY PROBLEMS. THE PLUNGER IS SEATED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868423 3ML SYRINGE 22G X 1 RP SYRINGE, PISTON FMF CARDINAL HEALTH 8881513231 22K375 10884521012714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown