BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET

    MDR report key: 11644755 · Received April 9, 2021

    Report

    Report Number
    3006425876-2021-00301
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 22, 2021
    Report Date
    March 22, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE OPENED KIT CONTAINING VARIOUS COMPONENTS INCLUDING AN INTRODUCER NEEDLE FOR ANALYSIS. VISUAL ANALYSIS CONFIRMED THAT THE NEEDLE HUB WAS BROKEN AND SEPARATED. A PORTION OF THE DISTAL END OF THE HUB WAS STILL ADHERED TO THE NEEDLE CANNULA. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION WAS SLIGHTLY ROUGH AND UNIFORM. THE NEEDLE HUB CONTAINED A V-NOTCH ON THE HUB, WHICH IS CONSISTENT WITH PART NUMBER K-04300-019B. THE HUB OF THE NEEDLE WAS TESTED WITH THE MALE LUER GAUGE AND WAS WITHIN THE SPECIFIED RANGE. THIS INDICATES THAT THE LUER CONFORMS TO ISO 594-1:1986. ALTHOUGH THE CUSTOMER DID NOT REPORT A PRODUCT CODE, THE DAMAGED INTRODUCER NEEDLE HUB WAS CONFIRMED TO BE K-04300-019B. THE REPORT OF A SEPARATED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL EXAMINATION REVEALED THE HUB WAS PARTIALLY SEPARATED. BASED ON THE SAMPLE PROVIDED, DESIGN CAUSED OR CONTRIBUTED TO THIS EVENT. A NON-CONFORMANCE REQUEST WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. CORRECTED DATA: SECTION H.10. CORRECTED AS FOLLOWS: THE CUSTOMER RETURNED ONE OPENED KIT CONTAINING VARIOUS COMPONENTS INCLUDING AN INTRODUCER NEEDLE FOR ANALYSIS. VISUAL ANALYSIS CONFIRMED THAT THE NEEDLE HUB WAS BROKEN AND SEPARATED. A PORTION OF THE DISTAL END OF THE HUB WAS STILL ADHERED TO THE NEEDLE CANNULA. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION WAS SLIGHTLY ROUGH AND UNIFORM. THE NEEDLE HUB CONTAINED A V-NOTCH ON THE HUB, WHICH IS CONSISTENT WITH PART NUMBER K-04300-019B. THE HUB OF THE NEEDLE WAS TESTED WITH THE MALE LUER GAUGE AND WAS WITHIN THE SPECIFIED RANGE. THIS INDICATES THAT THE LUER CONFORMS TO ISO 594-1:1986. ALTHOUGH THE CUSTOMER DID NOT REPORT A PRODUCT CODE, THE DAMAGED INTRODUCER NEEDLE HUB WAS CONFIRMED TO BE K-04300-019B. THE REPORT OF A SEPARATED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL EXAMINATION REVEALED THE HUB WAS PARTIALLY SEPARATED. BASED ON THE SAMPLE PROVIDED, DESIGN CAUSED OR CONTRIBUTED TO THIS EVENT. A NON-CONFORMANCE REQUEST WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE OPENED KIT CONTAINING VARIOUS COMPONENTS INCLUDING AN INTRODUCER NEEDLE FOR ANALYSIS. VISUAL ANALYSIS CONFIRMED THAT THE NEEDLE HUB WAS BROKEN AND SEPARATED. A PORTION OF THE DISTAL END OF THE HUB WAS STILL ADHERED TO THE NEEDLE CANNULA. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION WAS SLIGHTLY ROUGH AND UNIFORM. THE NEEDLE HUB CONTAINED A V-NOTCH ON THE HUB, WHICH IS CONSISTENT WITH PART NUMBER K-04300-019B. THE HUB OF THE NEEDLE WAS TESTED WITH THE MALE LUER GAUGE AND WAS WITHIN THE SPECIFIED RANGE. THIS INDICATES THAT THE LUER CONFORMS TO ISO 594-1:1986. ALTHOUGH THE CUSTOMER DID NOT REPORT A PRODUCT CODE, THE DAMAGED INTRODUCER NEEDLE HUB WAS CONFIRMED TO BE K-04300-019B. THE REPORT OF A SEPARATED NEEDLE HUB WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL EXAMINATION REVEALED THE HUB WAS PARTIALLY SEPARATED. BASED ON THE SAMPLE PROVIDED, DESIGN CAUSED OR CONTRIBUTED TO THIS EVENT. A CAPA WAS PREVIOUSLY OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PUNCTURE OF THE VENA SUBCLAVIA WAS WITHOUT ANY PROBLEMS. HOWEVER, AFTER THE WIRE WAS PLACED, THE PUNCTURE NEEDLE WAS REMOVED. THIS CAUSED THE NEEDLE HUB TO BREAK. THE REMAINING NEEDLE COULD BE REMOVED VIA THE WIRE." NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PUNCTURE OF THE VENA SUBCLAVIA WAS WITHOUT ANY PROBLEMS. HOWEVER, AFTER THE WIRE WAS PLACED, THE PUNCTURE NEEDLE WAS REMOVED. THIS CAUSED THE NEEDLE HUB TO BREAK. THE REMAINING NEEDLE COULD BE REMOVED VIA THE WIRE."NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PUNCTURE OF THE VENA SUBCLAVIA WAS WITHOUT ANY PROBLEMS. HOWEVER, AFTER THE WIRE WAS PLACED, THE PUNCTURE NEEDLE WAS REMOVED. THIS CAUSED THE NEEDLE HUB TO BREAK. THE REMAINING NEEDLE COULD BE REMOVED VIA THE WIRE." NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541293 ARROW CVC SET CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1