BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

    MDR report key: 12508497 · Received September 21, 2021

    Report

    Report Number
    3002682307-2021-00506
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 18, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-21. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2012110. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE, VIDEO, AND PHYSICAL SAMPLES WERE RETURNED FOR ANALYSIS BY OUR QUALITY ENGINEER TEAM. THROUGH EVALUATION OF THE SAMPLES, LEAKAGE THROUGH THE PLUNGER ROD COULD BE OBSERVED. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS IDENTIFIED TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY RESULT DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE. A QUALITY INITIATIVE HAS BEEN OPENED WITH THE AIM OF REDUCING THIS TYPE OF DEFECT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SEAL OF THE PLUNGER AND SYRINGE IS NOT GOOD, AND LEAKAGE OCCURRED DURING USE".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). INVESTIGATION SUMMARY: THE TEAM HAS BEEN PROVIDED WITH A PICTURE AND A VIDEO OF THE AFFECTED SAMPLE. THE TEAM WAS ABLE TO CONFIRM A PROBLEM IN THE SEAL OF THE SYRINGE, CONFIRMING THE CUSTOMER EXPERIENCE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE CUSTOMER FEEDBACK OF THE ISSUE AND THE PROVIDED PICTURES OF THE SAMPLE, THE TEAM THAT ROOT CAUSE COULD BE PRODUCED DUE TO A DAMAGE IN THE PLUNGER LIP WHICH CAUSED THE REPORTED LEAK ISSUE. THIS DAMAGE COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SEAL OF THE PLUNGER AND SYRINGE IS NOT GOOD, AND LEAKAGE OCCURRED DURING USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401738 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown