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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 CV-15703
Device Problem Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports the guide is in poor condition because it was deformed when passing it and when it was removed it was split. The device was replaced and a delay was reported 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 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 Key7450472
MDR Text Key106263240
Report Number9680794-2018-00084
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,HEALTH PR
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 04/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCV-15703
Device LOT Number14F17J0367
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/27/2017
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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