BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML

    MDR report key: 9764132 · Received February 27, 2020

    Report

    Report Number
    3002682307-2020-00069
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 10, 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH SAMPLES FOR CATALOG 309110 LOT 1911261 TO INVESTIGATE FOR THIS RECORD. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THESE PROVIDED SAMPLES. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM WAS PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. 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 THE SYRINGE S2 10ML EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: LEAKING 10 ML SYRINGES HAVE INCREASINGLY APPEARED ON ENDOSCOPY.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE S2 10ML EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: LEAKING 10 ML SYRINGES HAVE INCREASINGLY APPEARED ON ENDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230520 SYRINGE S2 10ML SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other