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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-21242-X1A
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This report is for the first in a series of two consecutive product problems with the same patient. The second issue has been reported under mdr # 1036844-2016-00469.
 
Event Description
It was reported the procedure was being performed in the trauma bay. The physician inserted the guide wire through the needle. At which time, he attempted to remove the wire and it unraveled. He felt the wire became caught on the needle and could not withdraw without pulling both needle and guidewire. As a result, a second kit was used.
 
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Brand NameMAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIMICRO
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 Key5876844
MDR Text Key52126511
Report Number1036844-2016-00468
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Catalogue NumberCDC-21242-X1A
Device Lot Number23F16D0196
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 Received07/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2016
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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