BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 8692149 · Received June 12, 2019

    Report

    Report Number
    3002682307-2019-00354
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 24, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. BD HAS BEEN PROVIDED A SAMPLE FOR CATALOG 300296 LOT 1812183 TO INVESTIGATE FOR THIS RECORD. VISUAL INSPECTION OF THE RETURNED SAMPLE PRESENTED THE BARREL BROKEN. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE MATERIAL USED TO MANUFACTURE DISCARDIT 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 TIP OF THE BARREL. BASED ON THIS FACT, BD BELIEVES THAT THE SYRINGE TIP COULD BREAK BECAUSE OF ANY IMPERCEPTIBLE DAMAGE IN THE BARREL DUE TO USE OR SOME STRONG CONDITION DURING HANDLING OR USE OF THE PRODUCT. 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 20ML THE SYRINGE WAS CRACKED AT THE BOTTOM. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: SYRINGE CRACKED AT THE BOTTOM, REMOVED IMMEDIATELY. CHECK ON OTHER SYRINGES: NO ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE# (B)(6). 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 20ML THE SYRINGE WAS CRACKED AT THE BOTTOM. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SYRINGE CRACKED AT THE BOTTOM, REMOVED IMMEDIATELY. CHECK ON OTHER SYRINGES: NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485573 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. 1812183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other