BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE W/ NEEDLE

    MDR report key: 8765026 · Received July 5, 2019

    Report

    Report Number
    3002682307-2019-00394
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 18, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    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

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301947 LOT 1811160 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DESPITE THE FACT THAT ANY HIGH VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARDIT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE W/ NEEDLE HAD FOREIGN MATTER IN THE CAP AND TUBING. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOTICED FOREIGN BLACK MATTER IN THE NEEDLE CAP AND FOREIGN WATER IN THE NEEDLE TUBING AFTER UNWRAPPED THE PACKAGE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE W/ NEEDLE HAD FOREIGN MATTER IN THE CAP AND TUBING. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOTICED FOREIGN BLACK MATTER IN THE NEEDLE CAP AND FOREIGN WATER IN THE NEEDLE TUBING AFTER UNWRAPPED THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559397 BD SYRINGE W/ NEEDLE SYRINGE W/ NEEDLE FMF BECTON DICKINSON, S.A. 1811160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other