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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CV-12122-F
Device Problems Difficult to Remove (1528); Unraveled Material (1664)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 02/19/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer alleges that during removal the swg (spring wire guide) unraveled from the stiff part. Impossible to remove the swg. It's reported that the catheter and swg were removed successfully. A new catheter was inserted.

 
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Brand NameARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 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 Key7403231
MDR Text Key104686574
Report Number3006425876-2018-00203
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK862056
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 03/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCV-12122-F
Device LOT Number71F17F0069
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2017
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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