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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 20 CM AGB ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problem Kinked (1339)
Patient Problem Death (1802)
Event Date 01/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This report is for the second in a series of three consecutive product issues with the same patient. The initial event has been reported under mdr # 1036844-2016-00144. The subsequent event has been reported under mdr # 1036844-2016-00146, which was filed as an adverse event - death. No sample will be returned for evaluation for this event.
 
Event Description
It was reported the catheter was being placed into a patient during a code situation. When trying to gain access the guide wire kinked. As a result, another kit was opened and used. The patient expired. A separate mdr has been filed as a death for a subsequent product issue on this patient.
 
Manufacturer Narrative
(b)(4) device evaluation: the reported complaint of the guide wire became kinked during insertion was confirmed. The customer returned one guide wire within a guide wire assembly. Visual examination revealed the guide wire displayed signs of use, dried blood was observed on the wire in several places and on the assembly. The distal end of the wire was protruding from the straightening tube and a kinked was observed just beyond the j- bend. The guide wire was removed from the assembly and two additional kinks were found. The three kinks were measured at 2. 2, 3. 2 and 13. 2 cm from the distal end. Microscopic examination confirmed that both welds were full and spherical. A manual tug test confirmed that both welds remain intact. The guide wire measured 600 mm in length and exhibited an outside diameter (od) at 0. 801 mm. The returned guide wire was within specification for length and od. A device history record review did not reveal any manufacturing related issues. Since the guide wire is always inserted through another component such as an introducer needle, ars syringe or introducer catheter and none of these components were 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 20 CM AGB
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
6103780131
MDR Report Key5481329
MDR Text Key39747701
Report Number1036844-2016-00145
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2017
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F15G1368
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2015
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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