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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) no sample will be returned for evaluation.
 
Event Description
It was reported during insertion the wire kinks when passing the needle. There was no patient death or complications reported. Follow up information confirms the catheter was being placed into the patient's jugular. The issue occurred when threading the wire through the needle. As a result, another kit was opened and that wire was used to complete the procedure. There was no patient death or complications reported.
 
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Brand NamePI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5744554
MDR Text Key48016368
Report Number1036844-2016-00333
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-45703-XP1A
Device Lot NumberUNKNOWN
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 Received06/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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