BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9355562 · Received November 21, 2019

    Report

    Report Number
    3002682307-2019-00618
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    May 9, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    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 NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301948,LOT 1811162 TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE MATERIAL USED TO MANUFACTURE DISCARD IT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100% THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE PLUNGER OF THE SYRINGE. BASED ON THIS FACT, BD BELIEVES THAT THE SYRINGE PLUNGER COULD BREAK BECAUSE OF A BLOCKAGE DURING MANUFACTURING IN THE PRIMARY PACKAGING 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 A SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA EXPERIENCED A BROKEN/DAMAGED PLUNGER ROD WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND THE PLUNGER ROD DAMAGED. THE LOT # PROVIDED BY CUSTOMER IS 1811162.

    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 A SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA EXPERIENCED A BROKEN/DAMAGED PLUNGER ROD WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND THE PLUNGER ROD DAMAGED. THE LOT # PROVIDED BY CUSTOMER IS 1811162.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154140 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other