BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 11704374 · Received April 21, 2021

    Report

    Report Number
    3002682307-2021-00147
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 18, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1810214. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH INSPECTION OF THE PICTURE, THE TIP OF THE SYRINGE WAS FOUND BROKEN. THE MATERIAL USED TO MANUFACTURE THE DISCARDIT SYRINGES IS SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN IN-LINE DETECTION SYSTEM THAT INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS SYRINGES WITH SIGNS OF DAMAGE. BASED ON THESE PREVENTIVE MEASURES, IT IS POSSIBLE THAT THIS INCIDENT WAS A CONSEQUENCE OF AN ERROR IN STORAGE CONDITIONS WITHIN THE MANUFACTURING FACILITY. IF THE BARREL IS STILL HOT WHEN THE PRODUCT IS STORED, IT MAY BECOME DAMAGED AND GO UNDETECTED WITHIN THE PACKAGING MACHINE. WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML BARREL TIP BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE PACKAGE, THE TIP OF BARREL OF SYRINGE WAS FOUND TO BE BROKEN.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#:(B)(6). 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 20ML BARREL TIP BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE PACKAGE, THE TIP OF BARREL OF SYRINGE WAS FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601692 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. 1810214

    Patients

    Seq Age Sex Outcome Treatment
    1