BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE WITH NEEDLE

    MDR report key: 9540539 · Received January 2, 2020

    Report

    Report Number
    3002682307-2019-00700
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 14, 2019
    Report Date
    February 28, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 300294 LOT 1902518 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO SHOWS A LEAKAGE THROUGH THE PLUNGER ROD. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE CAUSE OF THE PROBLEM MAY HAVE BEEN PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. BD RECOMMENDS THE USE OF 3 PCS BD SYRINGES WITH LUER LOCK TIP TO ADMINISTER MEDICATION VIA A SYRINGE PUMP. THE BD 3 PCS SYRINGE HAS A NATURAL RUBBER STOPPER WHICH PROVIDES A SMOOTHER PERFORMANCE IN TERMS OF PLUNGER ADVANCEMENT AT LOW SPEED. A LUER LOCK FITTING ENSURES A SAFER CONNECTION WITH THE INFUSION LINE COMPARED TO A LUER SLIP TIP, THUS REDUCING THE RISK OF DISCONNECTION OF THE INFUSION LINE. IN ADDITION, IT IS PREFERABLE THAT THE SYRINGE PUMP IS PLACED AT THE SAME HEIGHT OF THE PATIENT, HORIZONTALLY. THIS IS TO AVOID THE DIFFERENCE IN PRESSURE BETWEEN ATMOSPHERE AND VEIN AS IT COULD LEAD THE SYRINGE TO EMPTY BY ITS OWN. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT II¿ SYRINGE WITH NEEDLE HAS BEEN FOUND EXPERIENCING 10 OCCURRENCES OF BLOOD BACKFLOW DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DISCARDIT SYRINGE WAS USED IN DIALYSIS DEPT. ON INFUSION PUMP. HAD BLOOD BACKFLOW IN SYRINGE CAUSING BLOOD SPILLAGE.

    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 HAS BEEN REPORTED THAT THE BD DISCARDIT II¿ SYRINGE WITH NEEDLE HAS BEEN FOUND EXPERIENCING 10 OCCURRENCES OF BLOOD BACKFLOW DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DISCARDIT SYRINGE WAS USED IN DIALYSIS DEPT. ON INFUSION PUMP. HAD BLOOD BACKFLOW IN SYRINGE CAUSING BLOOD SPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4659 BD DISCARDIT II SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1902518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other