BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA

    MDR report key: 9261712 · Received October 31, 2019

    Report

    Report Number
    3002682307-2019-00584
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 17, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG 301945 LOT 1811382 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS BD HAS MANUFACTURED A CASE CARTON OF REFERENCE 301945 WITH A SHELF CARTON OF REFERENCE 300296 INSIDE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. AFTER REVIEWING THE BATCH HISTORY RECORDS, IT WAS CONFIRMED THAT THE REPORTED LOTS WERE MANUFACTURED AT THE SAME TIME. LOT 1811382 WAS MANUFACTURED IN PRODUCTION LINE 9 WHILE LOT 1812126 (20ML) WAS MANUFACTURED IN PRODUCTION LINE 10. THESE TWO SECONDARY PACKAGING MACHINES ARE MANAGED BY THE SAME OPERATOR, IN THIS CASE DUE TO A FAILURE OF GOOD MANUFACTURING PRACTICES. THE OPERATOR INTRODUCED ONE SHELF CARTON OF LOT 1812126 IN CASE CARTON OF LOT 1811382 PRODUCING THE REPORTED ISSUE. THE OPERATOR HAS BEEN MADE AWARE AT THE MANUFACTURING SITE. 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 A PACKAGE OF 20ML SYRINGES WITHOUT NEEDLES WERE FOUND IN THE BOX OF 100 SYRINGES S2 10ML 22GA 1-1/4IN BD CHINA WHEN OPENING IT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "WHEN THE CUSTOMER OPENED THE BOX OF 10ML SYRINGES WITH NEEDLES (MATERIAL #30195, BATCH # 1811382), HE FOUND THAT A MIDDLE LEVEL PACKAGE OF 20ML SYRINGES WITHOUT NEEDLES (MATERIAL # 300296, BATCH # 1812126) WERE MIXED."

    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 PACKAGE OF 20ML SYRINGES WITHOUT NEEDLES WERE FOUND IN THE BOX OF 100 SYRINGES S2 10ML 22GA 1-1/4IN BD CHINA WHEN OPENING IT BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE CUSTOMER OPENED THE BOX OF 10ML SYRINGES WITH NEEDLES (MATERIAL #30195, BATCH # 1811382), HE FOUND THAT A MIDDLE LEVEL PACKAGE OF 20ML SYRINGES WITHOUT NEEDLES (MATERIAL # 300296, BATCH # 1812126) WERE MIXED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053385 SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811382

    Patients

    Seq Age Sex Outcome Treatment
    1 Other