BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA

    MDR report key: 9284385 · Received November 6, 2019

    Report

    Report Number
    3002682307-2019-00591
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 22, 2019
    Report Date
    December 12, 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

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG 301947 LOT 1901202 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS SHOWS A BIG FLASH ON THE SYRINGE BARREL ON THE INJECTION POINT BELOW THE SYRINGE TIP. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BASED ON THE SAMPLE, THIS FLASH WAS PRODUCED IN THE INJECTION PROCESS, DUE TO A PUNCTUAL INCREASE OF THE INJECTION PRESSURE OR AN ISSUE RELATED TO THE CLOSE OF THE MOLD. AFTER THE MOLDING PROCESS, THIS BARREL COULD BE DAMAGED DUE TO A BLOCKAGE PRODUCED BY THIS FLASH, AND CONSEQUENTLY THE DAMAGE INCREASED. 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 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA HAD FOREIGN MATTER AND LEAKED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE USED IT, SHE OPENED THE PACKAGE AND FOUND THE PROBLEM AS SHOWN IN THE PIC. THERE WAS A SHARP FOREIGN MATTER AT THE TOP OF BARREL, WHICH WAS THE SAME MATERIAL AS THE BARREL. AND IN THE FOREIGN BODY LEAKAGE, LEAKAGE IS OBVIOUS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE S2 10ML 21GA 1-1/2IN BD (B)(4) HAD FOREIGN MATTER AND LEAKED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE USED IT, SHE OPENED THE PACKAGE AND FOUND THE PROBLEM AS SHOWN IN THE PIC. THERE WAS A SHARP FOREIGN MATTER AT THE TOP OF BARREL, WHICH WAS THE SAME MATERIAL AS THE BARREL. AND IN THE FOREIGN BODY LEAKAGE, LEAKAGE IS OBVIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077566 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other