BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SP SYRINGE

    MDR report key: 8366437 · Received February 25, 2019

    Report

    Report Number
    3002682307-2019-00162
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 22, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A BHR FOR THE REPORTED BATCH WAS CONDUCTED CONFIRMING THIS WAS RELEASED ACCORDING TO DEFINED SPECIFICATIONS AND REQUIREMENTS INCLUDING STERILIZATION AND FINAL LAB TESTING: A) THERE WERE NO QN'S OR ISSUES ASSOCIATED WITH BATCH #8170894. THERE IS NO DOCUMENTATION FOR ANY ISSUE RELATED WITH LEAKAGE, AS REFERRED ON THE REPORTED ISSUE. B) ALL INSPECTIONS PERFORMED FROM FILLING TO CASE PACK WERE ACCEPTABLE. THIRTY (30) RETAINED SAMPLES FROM BATCH 8170894 HAVE BEEN INSPECTED FOR LEAKAGE. NO LIQUID, NEITHER CONDENSATION, WAS FOUND IN THE FLOW WRAP PACKAGE. CONCLUSION: AFTER BHR AND MANUFACTURING RECORDS REVIEW, THERE WERE NO ISSUES DOCUMENTED RELATED TO THE REPORTED COMPLAINT. THERE WERE NO QNS ISSUED DURING THE PRODUCTION OF BATCH #8170894 AND ALL INSPECTIONS WERE PERFORMED WITH CORRECT RESULTS. THEREFORE, IT HAS NOT BEEN FOUND ANY SPECIFIC CIRCUMSTANCES, FROM MANUFACTURING PROCESS, THAT COULD EXPLAIN THE DESCRIBED COMPLAINT. THE AFFECTED SYRINGE IS NOT AVAILABLE FOR OUR EVALUATION SO IT IS NOT POSSIBLE TO DO AN ACCURATE INVESTIGATION OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ SP SYRINGE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 POSIFLUSH¿ SP SYRINGE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161872 BD POSIFLUSH¿ SP SYRINGE SALINE FLUSH NGT BECTON DICKINSON, S.A. 8170894

    Patients

    Seq Age Sex Outcome Treatment
    1 Other