BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 18GA 1-1/2IN BD

    MDR report key: 9569690 · Received January 9, 2020

    Report

    Report Number
    3002682307-2019-00713
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 24, 2019
    Report Date
    January 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG 301948 LOT 1901118 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS SHOWED DAMAGED PRODUCT WHICH SEEMS TO HAVE BEEN OPENED BEFORE ARRIVAL TO THE CUSTOMER. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD HAS DETERMINED THAT NO RE-WORK WAS DONE WHICH PRODUCT OF THIS BATCH. BD HAS NOT BEEN ABLE TO ESTABLISH THE SPECIFIC ROOT CAUSE THEREBY INCUR THE REPORTED ISSUE. THE MOST PROBABLE ROOT CAUSE COULD BE RELATED TO THE STORAGE OR TRANSPORT OF THE PRODUCT AFTER PRODUCTION. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 160 SYRINGE S2 20ML 18GA 1-1/2IN BD EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY WAS COMPROMISED WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COMPLAINT WAS RECEIVED FROM A HEAD NURSE WHICH STATED THAT THE SHELF PACKAGING OF THE MATERIAL NO.301948 SYRINGE WAS DAMAGED WHEN THE SHELF PACKAGING WAS OPENED, AND THE LID WAS DAMAGED. THE INFORMATION OF ABOUT 160 DISPOSABLE STERILE SYRINGES INVOLVED IN THE COMPLAINT WAS MATERIAL NO. 301948 BATCH NO. 1903216.

    Additional Manufacturer Narrative · 1

    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 160 SYRINGE S2 20ML 18GA 1-1/2IN BD EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY WAS COMPROMISED WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COMPLAINT WAS RECEIVED FROM A HEAD NURSE WHICH STATED THAT THE SHELF PACKAGING OF THE MATERIAL NO.301948 SYRINGE WAS DAMAGED WHEN THE SHELF PACKAGING WAS OPENED, AND THE LID WAS DAMAGED. THE INFORMATION OF ABOUT 160 DISPOSABLE STERILE SYRINGES INVOLVED IN THE COMPLAINT WAS MATERIAL NO. 301948, BATCH NO. 1903216.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36015 SYRINGE S2 20ML 18GA 1-1/2IN BD SYRINGE FMF BECTON DICKINSON, S.A. 1901118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other