BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 8956508 · Received September 3, 2019

    Report

    Report Number
    3002682307-2019-00476
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 14, 2019
    Report Date
    October 29, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG LOTS: 1811192 AND 1803151 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS SHOWS THE YELLOW FILL OF THE BLISTER. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PACKAGING PROCESS HAS TWO MAIN STEPS. THE FIRST IS THE FORMING OF THE CAVITY BY INCREASING THE TEMPERATURE OF THE FILM. THE FILM AND THE PAPER OF THE UNIT PACK ARE THEN SEALED BY PRESSURE AND TEMPERATURE. IN THIS CASE, DUE TO A PUNCTUAL INCREASE OF THE TEMPERATURE DURING THE FORMING OF THE BLISTER CAVITY, THE FILM WAS BURNT PRODUCING THE YELLOW APPEARANCE. THESE PARAMETER VALUES HAVE BEEN CHECKED FINDING ALL OF THEM WITHIN SPEC. ADDITIONALLY, THE ABSENCE OF SEALING DEFECT IN THE PRODUCT IS EVALUATED AS PART OF IN-PROCESS INSPECTIONS. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA WAS DISCOLORED. THIS OCCURRED ON 200 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, RECEIVED A COMPLAINT FROM THE DOCTOR IN THE CT ROOM. THE SYRINGE WAS OPENED AND THE PACKAGE WAS FOUND TO BE YELLOW.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1811192. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2018-11-14. MEDICAL DEVICE LOT #: 1803151. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-08. 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 5 ML 22GA 1-1/4 IN BD (B)(6) WAS DISCOLORED. THIS OCCURRED ON 200 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, RECEIVED A COMPLAINT FROM THE DOCTOR IN THE CT ROOM. THE SYRINGE WAS OPENED AND THE PACKAGE WAS FOUND TO BE YELLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750638 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other