BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS

    MDR report key: 12533413 · Received September 27, 2021

    Report

    Report Number
    1213809-2021-00660
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    July 21, 2021
    Report Date
    October 10, 2021
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED THE REPORTED DEFECT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0100479. A REVIEW SHOWED INSUFFICIENT SILICONE ISSUE WAS REPORTED DURING THE PRODUCTION. PRODUCT WAS REQUALIFIED PER APPLICABLE ACCEPTABLE QUALITY LIMIT BEFORE PRODUCTION RESUMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER(S) IS/ARE ALLEGING AN EXCESSIVE AMOUNT OF SILICONE IN THE BARREL. IT IS CLOGGING THE VENTING MEDIA WHICH INHIBITS/PREVENTS AIR FROM EXITING THE PRODUCT (A PRE-SET ARTERIAL BLOOD GAS SYRINGE) AND THEREFORE FROM FILLING WITH THE CORRECT AMOUNT OF BLOOD, AND EXCESS SILICONE ALSO MIGRATES TO THE OUTSIDE OF THE LUER TIP WHICH CAUSES THE NEEDLE TO DISENGAGE FROM THE SYRINGE. [IN THIS APPLICATION, THE PLUNGER IS SET TO A PREDETERMINED FILL POINT, THE STICK IS MADE AND AIR IS SUPPOSED TO EXIT THE SYRINGE VIA THE VENTING MEDIA (BEING FORCED OUT BY THE ARTERIAL PRESSURE), AND THEREBY FILLING THE BARREL INTERIOR TO THE PRE-SET PLUNGER POSITION.]

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER ADDR: (B)(6). 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 THAT THE BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER(S) IS/ARE ALLEGING AN EXCESSIVE AMOUNT OF SILICONE IN THE BARREL. IT IS CLOGGING THE VENTING MEDIA WHICH INHIBITS/PREVENTS AIR FROM EXITING THE PRODUCT (A PRE-SET ARTERIAL BLOOD GAS SYRINGE) AND THEREFORE FROM FILLING WITH THE CORRECT AMOUNT OF BLOOD, AND EXCESS SILICONE ALSO MIGRATES TO THE OUTSIDE OF THE LUER TIP WHICH CAUSES THE NEEDLE TO DISENGAGE FROM THE SYRINGE. [IN THIS APPLICATION, THE PLUNGER IS SET TO A PREDETERMINED FILL POINT, THE STICK IS MADE AND AIR IS SUPPOSED TO EXIT THE SYRINGE VIA THE VENTING MEDIA (BEING FORCED OUT BY THE ARTERIAL PRESSURE), AND THEREBY FILLING THE BARREL INTERIOR TO THE PRE-SET PLUNGER POSITION.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432455 BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS SYRINGE FMF 0100479

    Patients

    Seq Age Sex Outcome Treatment
    1