BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERITONEAL LAVAGE CATH KIT:8FR

    MDR report key: 6331895 · Received February 15, 2017

    Report

    Report Number
    1036844-2017-00094
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 14, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    GBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PERITONEAL CATHETER AND A NON-ARROW CONNECTOR WERE RETURNED FOR EVALUATION. MICROSCOPIC EXAMINATION OF THE CATHETER REVEALED A CRACK 0.2CM FROM THE MOLD SEAM EMANATING FROM THE PROXIMAL LUER HUB OPENING AND EXTENDING APPROXIMATELY 1.6CM DOWN THE LUER HUB. PER THE COMPLAINT, A NON-ARROW CONNECTOR WAS INSERTED INTO THE HUB OF THE ARROW CATHETER. PER CATHETER GRAPHIC K-09000-001A REV. 4, THE FEMALE LUER TAPER ON THE ARROW CATHETER IS PER ISO 594-1. IT WILL ACCEPT A MALE CONNECTOR DESIGNED TO THE SAME ISO STANDARD. THE FEMALE LUER TAPER OF THE CATHETER COULD NOT BE ACCURATELY CHECKED WITH GAUGE GA-1130-005-38 DUE TO THE SPLIT IN THE HUB. THE TIP OF THE NON-ARROW CONNECTOR WAS CHECKED WITH GAUGE GA-TP-0057-003 3B TO SEE IF IT'S TAPER CONFORMED TO ISO 594-1. IT DID NOT FIT THE APPROPRIATE DEPTH INTO THE GAUGE, INDICATING THE TAPER OF THE NON-ARROW CONNECTOR IS NOT ISO 594-1 COMPLIANT. AN ATTEMPT WAS MADE TO INSERT THE NON-ARROW CONNECTOR INTO THE LUER HUB OF THE ARROW CATHETER. THE CONNECTOR WOULD ONLY ENTER 2MM INTO THE LUER HUB BEFORE THE EXISTING SPLIT IN THE HUB STARTED TO OPEN. OTHER REMARKS: MEASUREMENT OF LUER GAUGE GA-1130-005-38 SHOWED THAT AN ISO 594-1 COMPLIANT MALE LUER SHOULD ENTER A MINIMUM OF 7MM INTO A ISO 594-1 COMPLIANT FEMALE LUER. BOTH THE FUNCTIONAL TEST AND THE MALE LUER GAUGE INDICATE THE CUSTOMER'S NON-ARROW CONNECTOR IS INCOMPATIBLE WITH THE ARROW PERITONEAL CATHETER. THE REPORT THAT THE FEMALE LUER HUB SPLIT DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED THE NON-ARROW CONNECTOR THEY WERE TRYING TO USE WITH THE ARROW CATHETER. THE CONNECTOR WAS TOO LARGE TO FIT INTO THE ARROW LUER HUB AND FORCING IT INTO THE HUB WOULD HAVE SPLIT THE HUB. A DHR REVIEW WAS PERFORMED AND IT DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. BASED ON THE USE OF AN INCOMPATIBLE CONNECTOR WITH THE ARROW CATHETER, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. HOWEVER, THE INVESTIGATION OF SAID DEVICE IS STILL IN PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES ""PERITONEAL LAVAGE CATHETER 8 FR WAS SPLITTING ON THE END IN WHICH THE CONNECTOR WAS APPLIED". ALLEGED DEFECT WAS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT. IT WAS REPORTED THERE WAS NO DELAY OR INTERRUPTION IN THERAPY. THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "PERITONEAL LAVAGE CATHETER 8 FR WAS SPLITTING ON THE END IN WHICH THE CONNECTOR WAS APPLIED". ALLEGED DEFECT WAS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT. IT WAS REPORTED THERE WAS NO DELAY OR INTERRUPTION IN THERAPY. THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115343 ARROW PERITONEAL LAVAGE CATH KIT:8FR CATHETER, PERITONEAL GBW ARROW INTERNATIONAL INC. 23F16A0304

    Patients

    Seq Age Sex Outcome Treatment
    1