BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 1 1/2 IN. BD ECLIPSE¿ 5 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6418932 · Received March 20, 2017

    Report

    Report Number
    9610847-2017-00016
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    March 1, 2017
    Report Date
    May 26, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: TWO UNUSED SAMPLES IN SEALED PACKAGES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED NO DEFECTS OR ABNORMALITIES AROUND THE NEEDLE SHIELD AND THE C-HOOK ON THE NEEDLE HUB. THE NEEDLE SHIELD WAS THEN ACTIVATED PER THE IFU. NO DOUBLE CLICKING WAS OBSERVED. NO RESISTANCE WAS FELT WHEN COVERING THE NEEDLE SHIELD OVER THE NEEDLE. A SINGLE CLICK WAS HEARD WHEN THE NEEDLE SHIELD WAS FINALLY ACTIVATED. NO DEFECTS OR ABNORMALITIES WERE OBSERVED DURING ACTIVATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6210840. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT HAS NOT BEEN DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THE SAMPLES RECEIVED HAVE BEEN FORWARDED TO THE NEEDLE MANUFACTURING SITE IN (B)(4) FOR FURTHER EVALUATION. UPON COMPLETION OF (B)(4) SECONDARY INVESTIGATION, A SECOND SUPPLEMENTAL REPORT WILL BE FILED. REMEDIAL ACTION REQUIRED: CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016.

    Additional Manufacturer Narrative · 1

    RESULTS: A SECONDARY EVALUATION OF THE TWO UNUSED SAMPLES WAS CONDUCTED BY THE MANUFACTURING SITE IN (B)(4). A VISUAL INSPECTION REVEALED THAT THE SAMPLES HAD BEEN ACTIVATED APPROPRIATELY. AS PREVIOUSLY REPORTED, REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6210840. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). DEVICE EVALUATION: A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE BECAUSE THE SHIELD DID NOT FIT WELL OVER THE NEEDLE. THE OPERATOR HAD TO GUIDE THE SHIELD DURING THE CLOSURE BUT HIS/HER FINGER SLIPPED AND A NEEDLE STICK INJURY OCCURRED. THE OPERATOR WELT TO THE ED "FOR THE NECESSARY CHECK". THE PATIENT WAS KNOWN (B)(6) NEGATIVE. NO FURTHER CONSEQUENCE WAS REPORTED FOR THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200902 22 G X 1 1/2 IN. BD ECLIPSE¿ 5 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE FMI BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6210840

    Patients

    Seq Age Sex Outcome Treatment
    1 Other