BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 11944306 · Received June 5, 2021

    Report

    Report Number
    2243072-2021-01620
    Event Type
    Malfunction
    Date Received
    June 5, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THE SALINE FLUSHES ARE NOT WORKING CORRECTLY. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. IT COULD BE POSSIBLE THE CUSTOMER HAD PRODUCT ON THE HIGHER END OF SPECIFICATION INDUCING MORE FORCE THAN NORMAL REQUIRED TO EXPEL THE SOLUTION. AS THE LOT PROVIDED IS 'UNKNOWN,' A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT IMPROPER SILICONE APPLICATION WITHIN THE SYRINGE BARREL CAN CREATE PLUNGER RESISTANCE. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE SILICONE APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE SILICONE IS UNIFORMLY APPLIED TO THE SYRINGE BARREL. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 10ML REG PR SALINE 10ML FILL HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: ¿WE HAVE HAD REPORTS OF THE SALINE FLUSHES (10ML) NOT WORKING CORRECTLY. IT FLUSHES OK TO ABOUT 5-6 ML POINT AND THEN QUITS. YOU HAVE TO APPLY EXTREME PRESSURE TO MAKE IT FLUSH FURTHER. PLEASE LET US KNOW IF YOU EXPERIENCE THESE ISSUES AND SAVE US THE SYRINGES SO THAT WE WILL HAVE LOT NUMBERS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840691 SYRINGE 10ML REG PR SALINE 10ML FILL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 306546 UNKNOWN 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1