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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-25703-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2016
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).
 
Event Description
It was reported that during insertion in ns, resistance was met resulting in the guide wire kinking. As a result, a new kit was opened and used without issue. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: the report that the guide wire kinked during insertion was confirmed. Returned were a guide wire and an advancer. No other components were returned. The customer also provided a photo of the sample. Both of the returned components exhibited signs of use. There was blood residue on the advancer tip. The guide wire was bent in an arc from the tip to the 20cm marking. There were also two slight bends near the j-tip. A manual tug test confirmed that both welds were intact. The guide wire measured 60. 2 cm in length, which was consistent with guide wire graphic. The od of the guide wire measured 0. 795mm. This met specification of 0. 788 - 0. 826mm per guide wire graphic. The guide wire is used with other components during insertion; however, the customer did not provide any details about the procedure and only returned the guide wire. The instruction booklet describes suggested techniques to minimize the likelihood of guide wire damage during use. A review of the device history records did not reveal any manufacturing related issues. Since the guide wire is always inserted through another component during the procedure and no other components were returned, the probable cause of this issue could not be determined. No further action will be taken.
 
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Brand NameCVC SET: 3-LUMEN 7 FR X 20 CM
Type of DeviceARROWG+ARD CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5735513
MDR Text Key47745024
Report Number3006425876-2016-00186
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberCS-25703-E
Device Lot Number71F15J1990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2015
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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