BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARTERIAL CATH SET: 20GA X 8CM

    MDR report key: 7309610 · Received March 2, 2018

    Report

    Report Number
    3006425876-2018-00137
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 19, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K093050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED AN OPENED (B)(4) SET CONTAINING A STRAIGHT GUIDE WIRE, AN LDPE GUARD AND A SINGLE LUMEN ARTERIAL CATHETER FOR EVALUATION. NONE OF THE COMPONENTS SHOWED ANY OBVIOUS SIGNS OF USE. THE GUIDE WIRE WAS RETURNED WITHIN THE LDPE GUARD AND CATHETER. VISUAL INSPECTION REVEALED THE GUIDE WIRE HAD SEVERAL KINKS ALONG THE CENTER OF THE BODY. THE LDPE GUARD WAS SLIGHTLY DISTORTED IN SEVERAL LOCATIONS THAT WOULD HAVE BEEN CONSISTENT WITH THE KINKS IN THE GUIDE WIRE WHILE STILL PACKAGED. WHITE STRESS MARKS WERE OBSERVED AT THE DISTORTED LOCATION INDICATING THE GUARD HAD PREVIOUSLY BEEN KINKED. THE PRODUCT PACKAGING (CHEVRON POUCH) HAD SEVERAL FOLD MARKS WHERE IT APPEARED THE PACKAGING HAD BEEN FOLDED OVER ITSELF. THE DAMAGE OBSERVED IS CONSISTENT WITH DEFECTS RELATED TO SHIPPING AND HANDLING OF (B)(4) SETS. THE POUCHES THIS PRODUCT IS PACKAGED IN ARE LONG AND FOLDING THE POUCHES OVER DURING SHIPPING/HANDLING/STORAGE WILL CAUSE THE GUIDE WIRE AND LDPE GUARD TO KINK AT THE CENTER OF THE BODY. THE KINKS IN THE GUIDE WIRE WERE LOCATED 95, 113, 136, 158 AND 188 MM FROM ONE OF THE GUIDE WIRE WELDS. THE GUIDE WIRE LENGTH AND OUTER DIAMETER WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE KIT PACKAGING AND THE GUIDE WIRE AND NO RELEVANT ISSUES WERE IDENTIFIED. THE REPORTED COMPLAINT THAT THE GUIDE WIRE WAS FOUND KINKED PRIOR TO USE WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE RETURNED GUIDE WIRE CONTAINED SEVERAL KINKS ALONG THE CENTER OF THE GUIDE WIRE BODY AS WELL AS TO THE PROTECTIVE LDPE GUARD. THE DAMAGE TO THE PACKAGING, THE LDPE GUARD AND THE KINKS IN THE CENTER OF THE GUIDE WIRE ARE CONSISTENT WITH DAMAGE CAUSED BY SHIPPING AND HANDLING OF SAC-00820 SETS. SINCE THIS LOT WAS MANUFACTURED, THE PRODUCT LABELING HAS BEEN UPDATED TO CLEARLY INFORM THE CUSTOMER TO NOT BEND THE PRODUCT AND IS INTENDED TO REDUCE THE POTENTIAL FOR PRODUCT DAMAGE. A DEVICE HISTORY RECORD REVIEW WERE PERFORMED AND REVEALED NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. BASED ON THE OBSERVED DAMAGE AND THE CUSTOMER REPORT, THE PROBABLE CAUSE OF THIS ISSUE IS SHIPPING AND HANDLING RELATED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGES THE GUIDE IS BENT. THIS ISSUE WAS DETECTED WHEN THE CATHETER WAS OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THE GUIDE IS BENT. THIS ISSUE WAS DETECTED WHEN THE CATHETER WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153032 ARROW ARTERIAL CATH SET: 20GA X 8CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F17C1254

    Patients

    Seq Age Sex Outcome Treatment
    1