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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS Back to Search Results
Catalog Number CS-27702-E
Device Problems Kinked (1339); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion in the micu, resistance was met when inserting the guide wire resulting in the kinking of the wire. 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 by the customer was one guide wire with additional components that included the arrow raulerson syringe/introducer needle assembly. A visual examination of the guide wire revealed an opened j-tip. A manual tug test confirmed that both welds remain intact. The guide wire measured 602 mm in length and the outside diameter (od) measure. 788 mm. The returned guide wire was within specification for length and od per guide wire graphic (length: 596 - 604 mm and od: 0. 788- 0. 826 mm). Microscopic examination of the guide wire revealed one kink of off-set coils at 2. 5 cm from the distal tip. Visual inspection of the ars/needle assembly was performed and both appeared typical but used. A functional test was performed in an attempt to verify the complaint using the returned guide wire, the ars, and needle. The guide wire was inserted into the ars and needle four times each at a different orientation by rotating the syringe 1/4 turns at each insertion and with the plunger in and out. The guide wire passed through each time and no resistance was met. The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use. A device history records review other remarks: was performed with no evidence to suggest a manufacturing related issue. Based on these circumstances, operational context caused or contributed to the event. No further action will be taken.
 
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Brand NameCVC SET: 2-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 Key5700837
MDR Text Key46619952
Report Number3006425876-2016-00159
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 06/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue NumberCS-27702-E
Device Lot Number71F15K1182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2015
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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