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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN030925
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2020
Event Type  Malfunction  
Manufacturer Narrative

Qn#: (b)(4). The product (catalog# cv-22854-sr) is not intended for sale in the us. Similar product/component sold in the us. Two mdrs (two patients involved): 3006425876-2020-00537; 3006425876-2020-00538.

 
Event Description

The customer reports that the extension lumens were blocked during use. A new device was inserted.

 
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Brand NameARROW CVC SET: 4-LUMEN 8.5FR X 16CM
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 Key10178555
MDR Text Key196060544
Report Number3006425876-2020-00538
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
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 06/12/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN030925
Device Catalogue NumberCV-22854-SR
Device LOT Number71F19G1607
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/24/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/18/2019
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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