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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 7 FR X 16 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 7 FR X 16 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number AK-42702-CDC
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No sample will be returned for evaluation.
 
Event Description
It was reported the procedure was being performed on a male patient. The anesthesiologist experienced difficulty with the guide wire getting caught on the arrow raulerson syringe during insertion. As a result, the patient was stuck twice. There was no patient death or complications reported. Follow up information states the guide wire was kinked and they opened a separate guide wire to complete the procedure.
 
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Brand NameCVC KIT: 2-LUMEN 7 FR X 16 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 Key5853258
MDR Text Key51369724
Report Number1036844-2016-00460
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 07/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberAK-42702-CDC
Device Lot Number23F16C0482
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 Received07/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2016
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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