BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 8728133 · Received June 24, 2019

    Report

    Report Number
    3002682307-2019-00376
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    May 3, 2019
    Report Date
    July 16, 2019
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PHOTO AND SAMPLE FOR CATALOG 300296 LOT 1902133 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO AND SAMPLE IDENTIFIED A LEAKAGE THROUGH THE PLUNGER ROD. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD COULD DETERMINE A DAMAGE IN THE PLUNGER LIP OCCURRED. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. 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. AFTER THE EVALUATION OF THE RECEIVED SAMPLE, BD CONCLUDES THAT THE CAUSE OF THE PROBLEM WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED LIQUID PAST THE PLUNGER DURING USE WHILE DRAWING BACK AIR INTO THE DEVICE, RESULTING IN DISCARDING BLOOD TESTS AND MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INDICATES THAT THE SYRINGE IS LEAKING ON THE PLUNGER. SO SHE DRAWS AIR, THE LIQUID ESCAPES FROM THE PLUNGER. THIS HAS ALSO HAPPENED WITH BLOOD (5ML VERSION). THERE WAS NO PATIENT DAMAGE, BUT VARIOUS BLOOD TESTS AND MEDICATION HAD TO BE DISCARDED. THIS HAS HAPPENED IN ANESTHETICS AS WELL AS IN THE ANESTHESIA INTENSIVE CARE UNIT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED LIQUID PAST THE PLUNGER DURING USE WHILE DRAWING BACK AIR INTO THE DEVICE, RESULTING IN DISCARDING BLOOD TESTS AND MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INDICATES THAT THE SYRINGE IS LEAKING ON THE PLUNGER. SO SHE DRAWS AIR, THE LIQUID ESCAPES FROM THE PLUNGER. THIS HAS ALSO HAPPENED WITH BLOOD (5ML VERSION). THERE WAS NO PATIENT DAMAGE, BUT VARIOUS BLOOD TESTS AND MEDICATION HAD TO BE DISCARDED. THIS HAS HAPPENED IN ANESTHETICS AS WELL AS IN THE ANESTHESIA INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522568 BD DISCARDIT II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other