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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
Model Number IPN030885
Device Problems Complete Blockage (1094); Difficult to Flush (1251)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). It is unknown when the alleged issue was detected.

 
Event Description

It was reported that two from three lumens cannot be flushed or rinsed through.

 
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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 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 Key10345108
MDR Text Key201612146
Report Number3006425876-2020-00661
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN030885
Device Catalogue NumberCV-15703
Device LOT Number71F19H0305
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/08/2019
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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