BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM

    MDR report key: 6524221 · Received April 26, 2017

    Report

    Report Number
    8041187-2017-00037
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    March 27, 2017
    Report Date
    May 30, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE AND TEN UNUSED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION OF THE USED SAMPLE REVEALED A BROKEN CATHETER THAT APPEARED TO HAVE BEEN CUT BY A SHARP OBJECT. OF THE UNUSED SAMPLES, FOUR OR THE TEN SAMPLES WERE FROM LOT # 6295085 AND SIX WERE FROM LOT # 6230127. THE CUSTOMER'S REPORTED DEFECT WAS NOT OBSERVED ON ANY OF THE UNUSED SAMPLES. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT NUMBERS 6295085 AND 6230127 NO IRREGULARITIES DURING THE MANUFACTURING PROCESS. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: ALTHOUGH A BROKEN CATHETER WAS OBSERVED ON THE RETURNED USED SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. ADDITIONALLY, OUT QUALITY ENGINEER NOTES THAT THERE IS NO PROCESS IN THE MANUFACTURING FACILITY THAT COULD HAVE CAUSE THE CUSTOMER'S REPORTED DEFECT.

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6295085; MEDICAL DEVICE EXPIRATION DATE: 10/31/2021; DEVICE MANUFACTURE DATE: 10/21/2016. MEDICAL DEVICE LOT #: 6230127; MEDICAL DEVICE EXPIRATION DATE: 08/31/2021; DEVICE MANUFACTURE DATE: 8/17/2016. (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: FIVE PHOTOS WERE RETURNED FOR EVALUATION. A PHOTO INSPECTION REVEALED A USED AND BROKEN CATHETER. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT NUMBERS 6295085 AND 6230127 NO IRREGULARITIES DURING THE MANUFACTURING PROCESS. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: WITHOUT A SAMPLE, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM BROKE OFF IN A PATIENT'S ARTERY AND HAD TO BE REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305375 BD¿ ARTERIAL CANNULA WITH BD FLOWSWITCH¿ 20G X 45MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention