BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CE

    MDR report key: 11558226 · Received March 23, 2021

    Report

    Report Number
    3002682307-2021-00104
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/16/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0071149. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLE ARRIVED WITHOUT THE TIP CAP AND ABOUT HALF OF THE SOLUTION WAS USED. THE SAMPLE WAS ALSO RECEIVED WITH EXTENSION TUBING. THE SYRINGE WAS TESTED FOR PLUNGER MOVEMENT AND NO SIGNS OF RESISTANCE WERE DETECTED. THE SAMPLE WAS FURTHER ANALYZED TO ENSURE THAT THE PROPER AMOUNT OF SILICONE WAS APPLIED TO THE SYRINGE DURING THE MANUFACTURING PROCESS. A SMALL AMOUNT OF POWDER WAS APPLIED TO THE SYRINGE, INDICATING THE DISTRIBUTION OF THE SILICONE THROUGHOUT THE BARREL. THE POWDER CONFIRMS THAT SILICONE WAS DISTRIBUTED THROUGHOUT THE BARREL AS INTENDED. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. IT IS POSSIBLE THAT THE ISSUE WAS CAUSED BY THE EXTENSION TUBING OR THE CONNECTION WITH THE IV CANNULA. UNFORTUNATELY, THE EXTENSION TUBING RECEIVED COULD NOT BE PROPERLY TESTED AS THE SYRINGE COULD NOT BE CONNECTED WITH THE TUBING DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 10ML SALINE FILL CE HAD DIFFICULT PLUNGER MOVENET DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "UNABLE TO ASPIRATE OR FLUSH. WHEN CONNECTING THE EXTENSION TUBING AND POSIFLUSH SYRINGE TO IV CANNULA, THEY WERE UNABLE TO ASPIRATE OR FLUSH. HOWEVER, THE POSIFLUSH SYRINGE WAS ABLE TO ASPIRE AND FLUSH WHEN IT WAS NOT CONNECTED TO THE CANNULA."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 10ML SALINE FILL CE HAD DIFFICULT PLUNGER MOVENET DURING USE. THE FOLLOIWNG WAS REPORTED BY THE INITIAL REPORTER: "UNABLE TO ASPIRATE OR FLUSH WHEN CONNECTING THE EXTENSION TUBING AND POSIFLUSH SYRINGE TO IV CANNULA, THEY WERE UNABLE TO ASPIRATE OR FLUSH. HOWEVER, THE POSIFLUSH SYRINGE WAS ABLE TO ASPIRE AND FLUSH WHEN IT WAS NOT CONNECTED TO THE CANNULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453954 SYRINGE 10ML SALINE FILL CE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 0071149

    Patients

    Seq Age Sex Outcome Treatment
    1