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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 8 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 8 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-25802-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2016
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported that during insertion in ar, the user was unable to pass the guide wire through the arrow raulerson syringe smoothly resulting in the wire kinking. As a result, a new kit was opened and used without issue. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the report that the guide wire could not be advanced through the ars smoothly could not be confirmed. Returned were a guide wire from this complaint and an ars with a blue tip and an introducer needle that was used with the guide wire. The customer supplied a photo of the sample in the kit. The guide wire was kinked 3. 2cm from the distal weld. The od of the guide wire measured 0. 800mm. This met specification of 0. 788 - 0. 826 mm per guide wire graphic. The length of the guide wire measured 60. 3cm, which was consistent with the guide wire graphic. A manual tug test confirmed that both welds were intact. The guide wire was inserted into the ars and introducer needle four times with the plunger in and then out, rotating the sample 1/4 turn each time. No resistance was experienced passing the guide wire through the ars and needle. A review of the device history records did not reveal any manufacturing related issues. The distal end of the guide wire was kinked indicating difficulty had been experienced during the insertion. Based on the kinks and the test results with the ars, operational context caused or contributed to this event. No further action will be taken.
 
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Brand NameCVC SET: 2-LUMEN 8 FR X 20 CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5735407
MDR Text Key47744934
Report Number3006425876-2016-00184
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberCS-25802-E
Device Lot Number71F15J1504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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