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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-42703-P1A
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the physician inserted the line with ease but stated that the line frayed upon removal. Another catheter was not placed. Follow up information states the guide wire was frayed and the catheter is intact. The event occurred in the medical intensive care unit. A central line was placed in interventional radiology and not attempted again by the pulmonary critical care physicians. The ir central line access was placed in the right groin site. The central line that was attempted in the micu was being placed in the patient's internal jugular.
 
Manufacturer Narrative
(b)(4). The report that the guide wire frayed during removal was confirmed. Returned were a guide wire and a catheter marked 7fr x 20cm on the hub. The guide wire was unraveled at the distal end. The returned guide wire was approximately 81 cm in length. The outside diameter (od) measured 0. 0345". The interior of the guide wire was comprised of a safety ribbon and a core wire. The safety ribbon is welded at both ends of the guide wire and the core wire is only welded to the proximal end. The safety ribbon broke adjacent to the weld at the distal end. A manual tug test confirmed the proximal weld was intact. The size and structure of the returned wire did not match the wire supplied with the kit, which is nominally 0. 032" in diameter and 45 cm in length. The origin of the returned wire is not known. Per the catheter graphic a 0. 035" guide wire must be able to pass from catheter tip through distal extension line hub. A 0. 035" guide wire from lab inventory passed through the catheter without resistance. A device history record review was performed based on sales history and did not reveal any manufacturing related issues. The probable cause of the guide wire unraveling could not be determined based upon the sample and information provided. No further action will be taken.
 
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Brand NameMULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5919235
MDR Text Key53664714
Report Number1036844-2016-00489
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-42703-P1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2016
Was Device Evaluated by Manufacturer? Yes
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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