BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE XS

    MDR report key: 10001338 · Received April 27, 2020

    Report

    Report Number
    9616657-2020-00064
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 28, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 9235407, 9239399, 9248167, 9255893, AND 9239371. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THESE REPORTED INCIDENTS. TO FURTHER INVESTIGATE THESE ISSUES, FIVE PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH EXAMINATION OF THE PICTURE SAMPLES, BROWN STAINS WERE OBSERVED ON THE PRODUCT PACKAGES. IT HAS BEEN DETERMINED THAT THE STAINS WERE CREATED DURING THE STEAM STERILIZATION PROCESS. THE INTEGRITY OF THE PRODUCT AND THE STERILE BARRIERS HAVE NOT BEEN AFFECTED. THESE SPOTS APPEAR ONLY ON THE OUTSIDE OF THE PACKAGING AND DO NOT PERMEATE IN ANY WAY ONTO THE PRODUCT. FURTHERMORE, MICROBIAL PERMEABILITY TESTING, CYTOTOXICITY TESTING, AND TESTING FOR RESIDUAL SOLVENTS AND VOLATILE SPECIES HAS BEEN COMPLETED ON THE PACKAGES DISPLAYING THE BROWNISH STAIN. THE TESTING CONFIRMED THAT THEY DO NOT PRESENT ANY RISK TO THE USE OF THE PRODUCT AND HAVE NO IMPACT ON THE EFFECTIVENESS, STERILITY, QUALITY OR SAFETY OF BD POSIFLUSH¿ XS 10ML SALINE FLUSH SYRINGE. WE ARE CURRENTLY EXPLORING SEVERAL OPTIONS TO REDUCE AND ELIMINATE ANY BROWN STAINING THAT OCCURS ON THE PACKAGING. THE PICTURE SAMPLES DID NOT DISPLAY ANY SIGNS OF TORN PACKAGES; THEREFORE, OUR QUALITY TEAM WAS UNABLE TO FURTHER IDENTIFY THE DIRECT CAUSE OF THIS REPORTED INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 10ML SALINE XS EXPERIENCED PACKAGING TEARS WHILE OPENING LEAVING PAPER SHARDS IN STERILE FIELD/ROOM, AND LIQUID OR MOISTURE TRANSFER THROUGH TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 365 PIECES NOT CONFORM DUE TO STAINS / DESTROYED OR TEARING PACKAGES. UPDATE 9TH OF APRIL: STAIN ON THE PACKAGE AND BROKEN BLISTER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9235407, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2019-08-23, MEDICAL DEVICE LOT #: 9239399, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-08-27, MEDICAL DEVICE LOT #: 9248167, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-09-05, MEDICAL DEVICE LOT #: 9255893, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-09-12, MEDICAL DEVICE LOT #: 9239371, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2019-08-27.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 10 ML SALINE XS EXPERIENCED PACKAGING TEARS WHILE OPENING LEAVING PAPER SHARDS IN STERILE FIELD/ROOM, AND LIQUID OR MOISTURE TRANSFER THROUGH TOP WEB. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 365 PIECES NOT CONFORM DUE TO STAINS / DESTROYED OR TEARING PACKAGES. UPDATE 9TH OF APRIL: STAIN ON THE PACKAGE AND BROKEN BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467158 SYRINGE 10ML SALINE XS PREFILLED SALINE SYRINGE FMF BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other