BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 8719748 · Received June 20, 2019

    Report

    Report Number
    3002682307-2019-00369
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    May 21, 2019
    Report Date
    July 11, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH SAMPLES FOR CATALOG 300296 LOTS 1901128 AND 1902139 TO INVESTIGATE FOR THIS RECORD. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN BOTH SAMPLES. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD DETERMINED A DAMAGE IN THE PLUNGER ROD BY THE EVOLUTION OF THE PLUNGER WITH MAGNIFICATION. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THESE LOT ARE REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: AFTER THE EVALUATION OF THE RECEIVED SAMPLES, 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. ROOT CAUSE DESCRIPTION: DAMAGE IN THE PLUNGER LIP PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THESE LOT ARE REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE S2 20ML THE SYRINGE IS DRAWING AIR ON THE PLUNGER LIQUID PASSES THROUGH THE PLUNGER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: SYRINGE IS DRAWING AIR, PROBABLY ON THE STAMP; LIQUID / PROPOFOL PASSES THE STAMP, IT CAN NOT BE GUARANTEED THAT THE PATIENT GETS THE CORRECT AMOUNT OF MEDICATION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1901128, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 1902139, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-01-29. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE SYRINGE S2 20ML THE SYRINGE IS DRAWING AIR ON THE PLUNGER LIQUID PASSES THROUGH THE PLUNGER. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SYRINGE IS DRAWING AIR, PROBABLY ON THE STAMP; LIQUID / PROPOFOL PASSES THE STAMP, IT CAN NOT BE GUARANTEED THAT THE PATIENT GETS THE CORRECT AMOUNT OF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508458 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other