BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 2 ML SYRINGE

    MDR report key: 8675728 · Received June 6, 2019

    Report

    Report Number
    3002682307-2019-00349
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903009282
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS NOT PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 300298 LOT 1811147 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD BE 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. 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. REVIEW OF THE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD DISCARDIT¿ II 2 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "COMPLAINT: SYRINGE OOZES, NOT POSSIBLE TO INBIBE FULLY// USER WANTED TO FILL THE SYRINGE BUT IT WAS NOT POSSIBLE TO FILL WITH MAXIMUM VOLUME. (I THINK DUE TO THE AIR COMING IN). ¿SYRINGE OOZES¿. THERE IS LEAKAGE NEXT TO THE PLUNGER DURING SUCTION, NOT POSSIBLE TO FILL THE BARREL PROPERLY DID ANY MEDICATION LEAK OUT OF THE SYRINGE? YES, THE ABSORBED FLUID FLOWS OUT OF THE SYRINGE DURING SUCTION.(WHEN MOVING THE PLUNGER)."

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 LEAKAGE OCCURRED WITH A BD DISCARDIT¿ II 2 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "COMPLAINT: SYRINGE OOZES, NOT POSSIBLE TO INBIBE FULLY// USER WANTED TO FILL THE SYRINGE BUT IT WAS NOT POSSIBLE TO FILL WITH MAXIMUM VOLUME. (I THINK DUE TO THE AIR COMING IN). ¿SYRINGE OOZES¿. THERE IS LEAKAGE NEXT TO THE PLUNGER DURING SUCTION, NOT POSSIBLE TO FILL THE BARREL PROPERLY. DID ANY MEDICATION LEAK OUT OF THE SYRINGE? YES, THE ABSORBED FLUID FLOWS OUT OF THE SYRINGE DURING SUCTION.(WHEN MOVING THE PLUNGER.)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468035 BD DISCARDIT II 2 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811147 00382903009282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other