BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML LUER-LOK SYRINGE

    MDR report key: 8956708 · Received September 3, 2019

    Report

    Report Number
    8041187-2019-00698
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 16, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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 SUMMARY: SAMPLE EVALUATION: TWO ACTUAL SAMPLES WERE RETURNED FOR INVESTIGATION IN SEAL PACKAGE FROM BATCH#: 8292033. OUR QUALITY ENGINEER INSPECTED THE RETURNED UNITS AND CONFIRMED THE REPORTED OBSERVATION OF A COLOR CHANGE IN THE GRAPHIC PRINTING OF THE PRODUCT PACKAGING. THE PRINT ON THE PACKAGE IS STILL CLEAR AND LEGIBLE. NO DEFECTS OR ABNORMALITIES WERE IDENTIFIED ON THE PRODUCTS WITHIN THE PACKAGES. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE REPORTED BATCHES. THIS PRODUCT WAS RUN WITH A VALIDATED STERILIZATION PARAMETER SETTING AND PASSED THE STERILITY TEST ACCEPTANCE CRITERIA UPON RELEASE. NO CHANGES HAVE BEEN MADE TO THE MATERIAL USED FOR THE SYRINGE PRODUCT IN THE PAST YEAR. THEREFORE, A DEFINITIVE ROOT CAUSE OF THIS COLOR CHANGE COULD NOT BE DETERMINED. THE APPROPRIATE PERSONNEL HAVE BEEN MADE AWARE OF THIS REPORT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 5ML LUER-LOK¿ SYRINGE WAS DISCOLORED. THIS OCCURRED ON 2400 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE OPERATING ROOM OF THE EAST AND WEST HOSPITAL OF UNION MEDICAL COLLEGE HOSPITAL, IT WAS FOUND THAT WHEN THE SYRINGES WERE UNPACKED, THE INSIDE OF THE WRAPPING PAPER OF THE SYRINGES TURNED RED. IN THE PROCESS OF OPEN MEDIUM PACKAGE, IT WAS FOUND THAT THE RED COLOR TURNED FROM THE TOP TO THE BOTTOM, AND THE FIRST LAYER WAS BASICALLY NORMAL, WHICH BECAME MORE AND MORE RED WITH THE NEXT LAYER.

    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 #: 8326750. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2018-11-22. MEDICAL DEVICE LOT #: 8110013. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-20. MEDICAL DEVICE LOT #: 8292033. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2018-10-19. MEDICAL DEVICE LOT #: 8239344. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-27. 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 BD 5 ML LUER-LOK¿ SYRINGE WAS DISCOLORED. THIS OCCURRED ON 2400 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE OPERATING ROOM OF THE EAST AND WEST HOSPITAL OF (B)(6) HOSPITAL, IT WAS FOUND THAT WHEN THE SYRINGES WERE UNPACKED, THE INSIDE OF THE WRAPPING PAPER OF THE SYRINGES TURNED RED. IN THE PROCESS OF OPEN MEDIUM PACKAGE, IT WAS FOUND THAT THE RED COLOR TURNED FROM THE TOP TO THE BOTTOM, AND THE FIRST LAYER WAS BASICALLY NORMAL, WHICH BECAME MORE AND MORE RED WITH THE NEXT LAYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748276 BD 5ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other