BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9564187 · Received January 8, 2020

    Report

    Report Number
    3002682307-2019-00712
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 22, 2019
    Report Date
    January 29, 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 PROVIDED WITH A PHOTO AND A SAMPLE FOR CATALOG 301947 LOT 1901231 TO INVESTIGATE FOR THIS RECORD. VISUAL INSPECTION OF THE RETURNED SAMPLE PRESENTED A CRACK ON THE BARREL OF THE SYRINGE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD HAS CONCLUDED THAT THE BROKEN BARREL WAS PRODUCED IN THE PRIMARY PACKAGING MACHINE, IN THE SYRINGE FEEDER STATION, DUE TO AN INCORRECT ALIGNMENT OF THE SYRINGE PRODUCED THE RUPTURE OF THE BARREL. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA THERE WAS AN ISSUE WITH THE SYRINGE BEING CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE OPENED THE PACKAGE TO PUMP THE LIQUID, SHE FOUND THAT THERE WAS A LONG AND OBVIOUS CRACK ON THE BARREL OF THE SYRINGE, IT COULDN'T BE CONTINUED TO USE.

    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 BEFORE USE OF THE SYRINGE S2 10ML 21GA 1-1/2IN BD (B)(4) THERE WAS AN ISSUE WITH THE SYRINGE BEING CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN THE NURSE OPENED THE PACKAGE TO PUMP THE LIQUID, SHE FOUND THAT THERE WAS A LONG AND OBVIOUS CRACK ON THE BARREL OF THE SYRINGE, IT COULDN'T BE CONTINUED TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30055 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other