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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 14GA X 20CM

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ARROW INTERNATIONAL INC. ARROW CVC KIT: 14GA X 20CM Back to Search Results
Model Number IPN030979
Device Problems Crack (1135); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device (catalog # de-04701-cp) not intended for sale in the us. Similar device/component sold in the us.
 
Event Description
The customer reports that the needle hub cracked after puncture. During aspiration air was pulled.
 
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Brand NameARROW CVC KIT: 14GA X 20CM
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 Key10122890
MDR Text Key194689951
Report Number3006425876-2020-00495
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
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 05/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN030979
Device Catalogue NumberDE-04701-CP
Device Lot Number71F19K0463
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
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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