BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 5ML 22GA 1-1/4IN

    MDR report key: 9416305 · Received December 5, 2019

    Report

    Report Number
    3002682307-2019-00647
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1811135 TO INVESTIGATE FOR THIS RECORD. 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE LEAKAGE OCCURRED WITH A BD SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT WAS TREATED WITH A SYRINGE FOR INTRAVENOUS INJECTION OF DRUG SOLUTION DUE TO BLOOD DISEASES IN OUR HOSPITAL. DURING THE USE, THE SYRINGE WAS FOUND LEAKING AND COULD NOT BE USED, WHICH WASTED MEDICAL RESOURCES AND EXTENDED THE TREATMENT TIME.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 DURING USE LEAKAGE OCCURRED WITH A BD SYRINGE S2 5ML 22GA 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT WAS TREATED WITH A SYRINGE FOR INTRAVENOUS INJECTION OF DRUG SOLUTION DUE TO BLOOD DISEASES IN OUR HOSPITAL. DURING THE USE, THE SYRINGE WAS FOUND LEAKING AND COULD NOT BE USED, WHICH WASTED MEDICAL RESOURCES AND EXTENDED THE TREATMENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215412 BD SYRINGE S2 5ML 22GA 1-1/4IN PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1811135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other