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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-25703-E
Device Problems Kinked (1339); Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports that the dilator tends to kink and the tip of the dilator split during insertion. The device was replaced without issue.

 
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Brand NameARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of DeviceCATHETER, PERCUTANEOUS
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 Key7371237
MDR Text Key103534426
Report Number3006425876-2018-00178
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/29/2019
Device Catalogue NumberCS-25703-E
Device LOT Number71F17J0189
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/04/2017
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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