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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-16553-E
Device Problems Fluid Leak (1250); Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports: during catheter use, the lumen was occluded, when the lumen is verified a leak of liquid was evidenced in the base of the catheter (blue butterfly). The device was replaced.

 
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Brand NameARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX 31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8464138
MDR Text Key140310379
Report Number9680794-2019-00111
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,USER FACI
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 03/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCS-16553-E
Device LOT Number14F18C0497
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/03/2018
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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