BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE FILL SPKG

    MDR report key: 10022726 · Received May 4, 2020

    Report

    Report Number
    9616657-2020-00068
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 8, 2020
    Report Date
    May 5, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K153481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 4/27/2020. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9011582 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PHYSICAL SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, FOREIGN MATTER WAS OBSERVED ON THE PRODUCT PACKAGING. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED DURING THE STEAM STERILIZATION PROCESS. THE INTEGRITY OF THE PRODUCT AND THE STERILE BARRIERS HAVE NOT BEEN AFFECTED. 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¿ SF 10ML SALINE FLUSH SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML REG PR SALINE FILL SPKG HAD WATERMARKING IN THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 306553 BATCH NO: 9011582. IT WAS REPORTED THAT STAINS WERE NOTICED INSIDE THE PACKAGING. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: SUPPOSED TO BE A STERILE SYRINGE BUT HAS STAINS INSIDE THE PACKAGE. DATE RECEIVED FOR INTAKE: 13-APR-2020."

    Additional Manufacturer Narrative · 1

    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 10ML REG PR SALINE FILL SPKG HAD WATERMARKING IN THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 306553 BATCH NO: 9011582 IT WAS REPORTED THAT STAINS WERE NOTICED INSIDE THE PACKAGING. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: SUPPOSED TO BE A STERILE SYRINGE BUT HAS STAINS INSIDE THE PACKAGE. DATE RECEIVED FOR INTAKE: 13-APR-2020"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483733 SYRINGE 10ML REG PR SALINE FILL SPKG INTRAVASCULAR CATHETER NGT BECTON, DICKINSON AND CO. 306553 9011582 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other