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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-27702-E
Device Problems Partial Blockage (1065); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer alleges that the catheter was blocked and the fluid could not pass.The procedure was completed using another device.
 
Manufacturer Narrative
(b)(4).The customer returned an opened set with various components for investigation.The returned catheter had signs of use in the form of biological material on the interior and exterior of the catheter body and extension lines.No other anomalies were found.The proximal extension line of the returned catheter was attached to a lab syringe full of water.The plunger was depressed and the water exited the proximal skive.The distal extension line of the returned catheter was then attached to a lab syringe full of water.The plunger was depressed and resistance was met.A wire was then passed through the distal line and catheter body and dried blood exited the distal end.The plunger was again depressed and water exited accordingly.A device history record (dhr) review was performed with no relevant findings.The instructions for use (ifu) provided with this kit instructs the user to "prepare the catheter for insertion by flushing each lumen and clamping or attaching the injection caps to the appropriate extension line(s).Leave the distal extension line uncapped for guide wire passage." the customer complaint of a catheter blockage was confirmed by complaint investigation.When a lab syringe full of water was connected to the distal extension line, resistance was met when flushing the line.However, a wire was used to unclog the catheter.Significant amounts of coagulated blood were found in the catheter body.Once the blood was removed, the line was able to flush normally.Based on the sample as received, it was determined that operational context caused or contributed to this event.
 
Event Description
The customer alleges that the catheter was blocked and the fluid could not pass.The procedure was completed using another device.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of Device
CATHETER, PERCUTANEOUS
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6962682
MDR Text Key90534869
Report Number3006425876-2017-00483
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2018
Device Catalogue NumberCS-27702-E
Device Lot Number71F16B2339
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received11/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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