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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-25703-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion in icu, resistance was met resulting in the guide 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 kinked during insertion was confirmed. Returned was a guide wire. No other components were returned. The customer also provided a photo of the sample. The guide wire exhibited signs of use. It was kinked approximately 1. 5 and 2. 5cm from the bottom of the j-bend. It was also kinked near the 20 and 30 cm marks as well as 7 cm from the proximal end. A manual tug test confirmed that both welds were intact. The guide wire measured 68. 4 cm in length. The od of the guide wire measured 0. 846mm. Comparison with guide wire graphic showed that the returned guide wire did not match the nominal 0. 826mm od, 60cm long guide wire supplied with the kit. No information was available on the origin of the returned wire. A review of the device history records for the guide wire supplied with the reported kit did not reveal any manufacturing related issues. As a result, the probable cause of this issue could not be determined. No further action will be taken.
 
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Brand NameCVC SET: 3-LUMEN 7 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 Key5735572
MDR Text Key47746032
Report Number3006425876-2016-00188
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-25703-E
Device Lot Number71F15K0992
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? Yes
Date Device Manufactured10/15/2015
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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