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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).
 
Event Description
It was reported a second insertion attempt was being made into the patient's left femoral in the emergency department. During insertion the guide wire kinked. As a result, a 20cm cvc kit was opened and placed successfully.
 
Manufacturer Narrative
(b)(4). This report is for the second in a series of two consecutive product problems with the same patient. The first issue has been reported under mdr # 3003737899-2016-00037. Device evaluation: the reported complaint of the guide wire became kinked during insertion was confirmed. The customer returned one guide wire and several other components in an opened kit. The introducer needle and the catheter were not returned. Visual examination of the guide wire revealed one kink at the distal end of the wire. The kink was measured at 2. 5 cm from the distal weld. Microscopic examination confirmed the kink and that both welds were full and spherical. No other defects were observed. A manual tug test confirmed that both welds remain intact. The guide wire measured approximately 455mm in the total length and exhibited an outside diameter (od) measured 0. 801 mm. The returned guide wire was within specification for length and od per graphic (length: 450 - 458 mm and od: 0. 788- 0. 826mm). The other returned components, an 18 ga catheter from a catheter over needle assembly, two arrow raulerson syringe (ars) and dilator, all appeared used since dried blood was observed on both the outside and inside of these components. Other remarks: 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 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 guide wire is always inserted through another component and the introducer needle and catheter were 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 Key5892037
MDR Text Key52611794
Report Number3003737899-2016-00038
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 Initial

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