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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CDC-42703-P1A
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer returned one used spring-wire guide (swg) with the swg assembly. A visual inspection of the swg revealed one kink and a bend in the swg body. Microscopic examination of the guide wire confirmed the kink and bend. There are offset coils at the kink. Both welds were present and were observed to be full and spherical. The kink and bend in the swg were located approximately 2. 0 and 3. 4 cm from the distal end of the swg, respectively. The swg length and outer diameter were measured and were found to be within specification. A manual tug test confirmed that both welds remain intact. The lot number was not reported; however, a device history record (dhr) review was performed based on a lot number from the sales history data of the customer. No relevant findings were identified. 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 reported complaint that the swg was kinked was confirmed based on visual inspections of the returned sample. A kink and a bend were both found in the swg body. The returned guide wire met all relevant dimensional requirements and a dhr review did not identify any manufacturing related issues. 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 alleges that the guide wire kinked during use.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer alleges that the guide wire kinked during use.
 
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Brand NameARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
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 Key6910765
MDR Text Key247685900
Report Number1036844-2017-00356
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 09/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-42703-P1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2017
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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