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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 30CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 30CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number ASK-14854-KR
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports that after insertion of the catheter, one of the lumens was blocked. The catheter was removed , and a new device was used without incident.

 
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Brand NameARROW CVC KIT: 4-LUMEN 8.5FR X 30CM
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
keely mckinley
3015 carrington mill blvd
morrisville, NC 27560
9194334889
MDR Report Key8658806
MDR Text Key146667559
Report Number3006425876-2019-00390
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
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 05/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date08/01/2020
Device Catalogue NumberASK-14854-KR
Device LOT Number71F18E0925
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2018
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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