BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 9647972 · Received January 30, 2020

    Report

    Report Number
    3002682307-2020-00021
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 10, 2020
    Report Date
    February 27, 2020
    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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAS BEEN PROVIDED WITH PHOTOS OF CATALOG 306575 LOT 9052513 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS DID NOT CLEARLY IDENTIFY ANY DEFECT IN THE SYRINGE. RETAINED SAMPLES WERE ALSO REVIEWED AND ALL SAMPLES WERE IN GOOD CONDITION WITH NO BROKEN LUER LOCK. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE. A POSSIBLE ROOT CAUSE FOR THE BROKEN LUER LOCK WAS THE PRESENCE OF SILICONE IN THE OUTER PART OF THE TIP CAP. THE SILICONE STATION WAS TOTALLY FULL OF SILICONE WHICH CAUSED AN EXCESS OF DOSAGE INTO THE BARREL UP TO THE POINT OF STAINING THE OUTER PART OF THE TIP CAP. AS A RESULT, THE TIP CAP WAS THREADED TOO TIGHT BREAKING THE LUER LOCK. 40,000 UNITS WERE IDENTIFIED TO BE AFFECTED AND WERE SUBSEQUENTLY SCRAPPED. BD CONCLUDES THAT AN INCORRECT IDENTIFICATION AND DELIMITATION OF THESE NON-CONFORMANCE PRODUCTS OCCURRED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% LUER BROKE OFF. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INNER PART OF THE LUERLOCK CONNECTION HAS BROKEN OFF IN THE INFUSION SYSTEM. WHEN AN INFUSION IS DISPENSED AT THE TAP, THE INNER PART OF THE LUERLOCK OF THE NACL SYRINGE IS BROKEN OFF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% LUER BROKE OFF. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INNER PART OF THE LUERLOCK CONNECTION HAS BROKEN OFF IN THE INFUSION SYSTEM. WHEN AN INFUSION IS DISPENSED AT THE TAP, THE INNER PART OF THE LUERLOCK OF THE NACL SYRINGE IS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113787 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% N/A NGT BECTON DICKINSON, S.A. 9052513

    Patients

    Seq Age Sex Outcome Treatment
    1 Other