BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24 G X 0.56 IN. BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER

    MDR report key: 7060554 · Received November 27, 2017

    Report

    Report Number
    8041187-2017-00169
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    October 21, 2017
    Report Date
    December 10, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903813117
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7020262. MEDICAL DEVICE EXPIRATION DATE: 01/31/2022. DEVICE MANUFACTURE DATE: 03/12/2017. MEDICAL DEVICE LOT #: 6341140. MEDICAL DEVICE EXPIRATION DATE: 11/30/2021. DEVICE MANUFACTURE DATE: 01/16/2017. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 9 REPRESENTATIVE SAMPLES IN CLOSED PACKAGING WERE RETURNED FOR INVESTIGATION. BATCH 7020262, BATCH 6341140, BATCH 6341119, FIGURE 1: REPRESENTATIVE SAMPLES. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. NO ABNORMALITIES WERE OBSERVED ON ALL RETURNED SAMPLES. BATCH 7020262, BATCH 7020262, BATCH 7020262, BATCH 7020262, BATCH 6341140, BATCH 6341140, BATCH 6341140, BATCH 6341140, BATCH 6341119, ROOT CAUSE: THE ROOT CAUSE OF THE NONCONFORMANCE CANNOT BE CONFIRMED AS THE RETURNED SAMPLES SHOWED NO ABNORMALITIES. NO ABNORMALITIES WERE OBSERVED ON THE RETURNED SAMPLES DURING VISUAL INSPECTION. DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 7020262, CATALOGUE NUMBER 381311 AND ITS ASSEMBLED NEEDLE (AN) BATCH 7020297. PART NUMBER 8301323 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 6341140, CATALOGUE NUMBER 381311 AND ITS ASSEMBLED NEEDLE (AN) BATCH 6323051, PART NUMBER 8301323 WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 24 G X 0.56 IN. BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER BROKE OFF INSIDE AN INFANT. THE PIECE HAD TO BE SURGICALLY REMOVED AND DISCARDED. THIS MDR REPORTABLE IS CONSIDERED A SERIOUS INJURY AND MEDICAL INTERVENTION TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839427 24 G X 0.56 IN. BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10. 00382903813117

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention