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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 16 CM AGB+ ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 16 CM AGB+ ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CA-42703-P1A
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No sample will be returned for evaluation. This report is for the first in a series of two consecutive product problems with the same patient. The second issue has been reported under mdr # 3003737899-2016-00038.
 
Event Description
It was reported the procedure was being performed in the emergency department. During insertion into the patient's right femoral the clinician experienced an issue with the guide wire kinking. As a result, a second kit was opened. Follow up information confirmed the guide wire kinked when it was being inserted through the needle.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the reported complaint of the guide wire became kinked during insertion into the introducer needle could not be confirmed. The customer returned one guide wire and multiple other components in an opened kit. The introducer needle was not returned. Visual examination of the guide wire revealed one kinks at the distal end of the wire and the j- bend appeared opened. The kink was measured at 2. 9 cm from the distal weld. Microscopic examination confirmed the kink and also confirmed that both welds were full and spherical. A manual tug test confirmed that both welds remain intact. The guide wire measured approximately 450 mm in the total length and exhibited an outside diameter (od) measured 0. 793 mm. The returned guide wire was within specification for length and od per guide wire graphic (length: 450 - 458 mm and od: 0. 788- 0. 826mm). The other returned components, catheter, arrow raulerson syringe(ars) and dilator, all appeared used since dried blood was observed on both the outside and inside of these components. Functional testing was performed with the returned guide wire and each of these components separately. The guide wire passed through each component with no resistance. The instructions for use describe suggested techniques to minimize other remarks: the likelihood of guide wire damage during use. The device history record review was performed and did not reveal any manufacturing related issues. Since the introducer needle was not returned, the probable cause of this issue could not be determined. No further action will be taken.
 
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Brand NamePI CVC KIT: 3-L 7 FR X 16 CM AGB+
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5892020
MDR Text Key52615512
Report Number3003737899-2016-00037
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue NumberCA-42703-P1A
Device Lot Number13F16A0201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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