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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 16 CM AGB ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 16 CM AGB ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CDC-42703-XP1A
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problems Hematoma (1884); Blood Loss (2597)
Event Date 01/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). No sample will be returned for evaluation. This report is for the eighth in a series of ten consecutive product problems with the same patient. The first, second, third, fourth, fifth, sixth, seventh, ninth, and tenth have been reported under mdr # 1036844-2016-00186, 1036844-2016-00187, 1036844-2016-00188, 1036844-2016-00189, 1036844-2016-00190, 1036844-2016-00191, 1036844-2016-00192, 1036844-2016-00194, 1036844-2016-00195.
 
Event Description
Information was found during the maude event website search. It was reported that on (b)(6) 2016 the patient arrived in the emergency department coding with minimal vascular access available. Multiple iv attempts. Physician made multiple central line attempts to gain central venous access. Each attempt resulted in a kinked guide wire. The physician had to pull the equipment out of the patient and reattempt. Critical drugs were pushed peripheral lines and/or the io which was minimally successful. The patient had multiple hematomas to both femoral and left subclavian sites and lost blood related to the multiple attempts. Staff was able to access the ij using a 22 gauge needle at the end of the code.
 
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Brand NamePI CVC KIT: 3-L 7 FR X 16 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 Key5535744
MDR Text Key41479298
Report Number1036844-2016-00193
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 other
Reporter Occupation
Type of Report Initial
Report Date 03/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCDC-42703-XP1A
Device Lot NumberUNKNOWN
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 Received03/22/2016
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

Patient Treatment Data
Date Received: 03/30/2016 Patient Sequence Number: 1
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