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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-45703-1A
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No sample will be returned for evaluation.
 
Event Description
It was reported the procedure was being performed in the emergency department. The physician stated the guide wire has unraveled during the procedure. There was no injury to the patient. No patient death or complications reported. Follow up information states the guide wire was being fed through the needle. The guide wire became stuck during insertion or removal in some cases. A second kit was used to complete the procedure successfully. Patient care was delayed. In each case the physician had to remove the needle to safely remove the wire and then re-establish access. On at least one occasion they had to use a different insertion site.
 
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Brand Name3-L CVC KIT: 7 FR X 20 CM
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 Key6092466
MDR Text Key59619281
Report Number1036844-2016-00573
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993691
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 10/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue NumberCDC-45703-1A
Device Lot Number23F16E0704
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2016
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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