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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM CATHETER, INTRAVASCULAR, THERA

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM CATHETER, INTRAVASCULAR, THERA Back to Search Results
Catalog Number CA-22703
Device Problems Kinked (1339); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: defective guide wire, badly kinked. The reported defect was detected prior to patient use. No patient involvement reported.
 
Manufacturer Narrative
(b)(4). The sample was not returned; however, the customer did provide a photo of a severely bent and unraveled guide wire. The reported complaint of a damaged guide wire was confirmed by the customer photo. However, without the device to evaluation, complaint verification testing could not be performed. A device history record review was performed and no relevant findings were identified. The probable cause of this complaint could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports: defective guide wire, badly kinked. The reported defect was detected prior to patient use. No patient involvement reported.
 
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Brand NameARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
Type of DeviceCATHETER, INTRAVASCULAR, THERA
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7573589
MDR Text Key110359480
Report Number3003737899-2018-00071
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberCA-22703
Device Lot Number13F18A0523
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2018
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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