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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 6" CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 6" CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04706
Device Problems Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 01/15/2020
Event Type  Malfunction  
Manufacturer Narrative

Qn#: (b)(4). Preliminary evaluation of the returned device indicates the catheter is caught in the tray seal and compromising sterility of the device.

 
Event Description

It was reported that in (b)(6), the tip end of the catheter was found stick to the package, which caused the catheter could not be taken out and used after opening the package prior to the patient.

 
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Brand NameARROW CVC SET: 14 GA X 6"
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 Key10018603
MDR Text Key189645303
Report Number3006425876-2020-00430
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
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 05/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberES-04706
Device LOT Number71F17L1368
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2017
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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