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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CS-24301-E
Device Problems Kinked (1339); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 03/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports the swg (spring wire guide) was found kinked by the doctor prior to patient use.
 
Manufacturer Narrative
(b)(4). The customer returned an opened cs-24301-e set with various components, including a guide wire assembly for evaluation. None of the components showed evidence of use. The guide wire was returned fully retracted within the advancer tube with the cap on. Visual examination of the returned guide wire assembly revealed that all of the assembly components were returned and were assembled correctly. The set was returned opened and not all of the components were from the set were returned. Visual examination revealed two adjacent kinks in the center of the guide wire body. This damage is consistent with the guide wire coming in contact with other components during shipping and handling. Both welds were observed to be full and spherical. The kinks in the guide wire were located 53 and 63 mm from the proximal tip. The overall length and outer diameter of the returned guide wire were measured and were found to be within specification. A manual tug test confirmed both the distal and proximal welds are intact. A device history record review was performed on the packaging of the set and manufacturing of the swg and no relevant issues were identified. The report that the spring wire guide was found to be kinked prior to use was confirmed through visual examination of the returned sample. Visual examination revealed two kinks in the guide wire body. The damage observed is consistent with damage during transit. A device history record review was performed with no relevant findings. Based on the sample received, it was determined that shipping and handling caused or contributed to this issue. Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
The customer reports the swg (spring wire guide) was found kinked by the doctor prior to patient use.
 
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Brand NameARROW CVC SET: 16 GA X 8" (20 CM)
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7534186
MDR Text Key108991932
Report Number3006425876-2018-00319
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K900263
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 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/24/2019
Device Catalogue NumberCS-24301-E
Device Lot Number71F17G1976
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2017
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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