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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7FR X 16CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 7FR X 16CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number SA-22703-EU
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional information: this product is not sold in the us. The 510k # provided is for a similar product that is sold in the us.
 
Event Description
It was reported that during insertion into the patient's right internal jugular, the doctor was unable to thread the guide wire through the raulerson syringe. After removing the guidewire, the j tip was found bent. As a result, the doctor used the straight side of the guide wire to insert into the catheter. 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
(b)(4). Device evaluation: the report that the physician was unable to insert the guide wire through the arrow raulerson syringe (ars) was confirmed. One guide wire assembly and an arrow raulerson syringe (ars) were returned. No defects or anomalies were observed on the ars. The guide wire had two kinks located 1 and 2 cm from the j-tip weld. A manual tug test on both ends of the guide wire found both welds intact with no unraveling or separations. The guide wire graphic specifies the length at 450 +/- 6 mm and the diameter at. 78/. 81 mm. The diameter of the guide wire measured 0. 800 mm. The length was measured at 450 mm. Both measurements met specifications. Functional testing was performed using a lab inventory guide wire with a measured diameter of. 805 mm and a guide wire advancer / straightening tube. The j-end of the guide wire was inserted into the raulerson syringe four times with the plunger in and then out, rotating the sample 1/4 turn between insertions. Resistance was encountered at one of the orientations with the plunger in and out. Resistance is encountered as soon as the guide wire enters ars plunger. A device history record review was performed and did not reveal any manufacturing related cause. Other remarks: the probable cause of this issue is manufacturing related. Further investigation of this issue has been initiated.
 
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Brand NameCVC SET: 3-LUMEN 7FR X 16CM
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 Key5942040
MDR Text Key54401629
Report Number3006425876-2016-00282
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSF
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 08/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSA-22703-EU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2016
Was Device Evaluated by Manufacturer? Yes
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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