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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 2-L 7 FR X 16 CM ANTIMICROBI CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 2-L 7 FR X 16 CM ANTIMICROBI CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CDC-45703-XP1A
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog # corrected to cdc-45703-xp1a. The customer returned a guide wire assembly for evaluation. The guide wire was returned within the advancer tube and showed evidence of use. Neither the product lid stock nor any other components were returned. The guide wire was observed to be kinked towards the distal end of the body. The distal j-bend was slightly deformed but intact. Microscopic examination confirmed the kink in the guide wire body. Both welds were present and were observed to be full and spherical. Dried blood was observed on the guide wire body indicating use. The guide wire was kinked 25 mm from the distal tip. The overall length and outer diameter of the guide wire were measured and were found to be within specification. The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle (as is supplied in kit cdc-45703-xp1a) to functionally test the guide wire. Slight resistance was met while passing the kinked portion of the guide wire through the insertion components. A manual tug test confirmed that both the distal and proximal welds were intact. Other remarks: the instructions-for-use (ifu) provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use. The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire. The report that the guide wire kinked during use was confirmed through examination of the returned sample. The guide wire was kinked 25 mm from the distal tip. The returned guide wire met all relevant dimensional requirements. Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports that the doctor attempted to place a central line in the left ij and the swg (spring wire guide) bent 90 degrees in the tissue of the patient and the dilator was not very good. No patient injury or consequence. The patient's condition is reported as fine. Therapy was not delayed/interrupted.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports that the doctor attempted to place a central line in the left ij and the swg (spring wire guide) bent 90 degrees in the tissue of the patient and the dilator was not very good. No patient injury or consequence. The patient's condition is reported as fine. Therapy was not delayed/interrupted.
 
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Brand NameARROW PI CVC KIT: 2-L 7 FR X 16 CM ANTIMICROBI
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6908636
MDR Text Key250780148
Report Number1036844-2017-00352
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-45703-XP1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2017
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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