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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN030863
Device Problems Obstruction of Flow (2423); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2019
Event Type  Malfunction  
Manufacturer Narrative

Qn#: (b)(4).

 
Event Description

The customer reports difficulty in collecting a sample from the distal line. The reflow was very difficult via the distal line. It was observed that 2 lines (proximal and distal) were kinked and stuck on the internal side of the bandage. The lines were cut. The cut lines were clamped, the device was removed, and new device inserted.

 
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Brand NameARROW CVC SET: 3-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 Key9430509
MDR Text Key179265930
Report Number3006425876-2019-01035
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK862056
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 12/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIPN030863
Device Catalogue NumberCV-12853
Device LOT Number71F19G0405
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2019
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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