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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number FR-42854-IP
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device (catalog# fr-42854-ip) is not intended for sold in the us. Similar device sold in the us. It is unknown if the device sample is available for evaluation.
 
Event Description
The customer reports the doctor noticed, during insertion, the middle line of the catheter had a hole. The device was replaced.
 
Manufacturer Narrative
Qn# (b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. Without the device to evaluate the complaint could not be confirmed and the probable cause 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 the doctor noticed, during insertion, the middle line of the catheter had a hole. The device was replaced.
 
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Brand NameARROW CVC KIT: 4-LUMEN 8.5FR X 16CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
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 Key7609595
MDR Text Key111339885
Report Number3006425876-2018-00404
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
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 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2019
Device Catalogue NumberFR-42854-IP
Device Lot Number71F18B2654
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 Received07/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2018
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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