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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CA-11142-A
Device Problems Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 09/09/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer reports an inconsistent latex free labelling on the lid of the stock. The lid shows both "latex free" and "contains latex" labelling. The issue was detected during incoming inspection/inventory review.

 
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Brand NameARROW MULTI-LUMEN/PSI KIT
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 Key9083345
MDR Text Key167011281
Report Number3006425876-2019-00733
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
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,Followup
Report Date 09/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCA-11142-A
Device LOT Number71F18J0795
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/21/2018
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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