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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-12853
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the nurse could not aspirate and get blood return and it felt like sucking air.The nurse takes away the three-way stopcock and aspirate directly from the catheters blue extension.The user gets a blood return but when injects saline some blood comes through the blue extension on the cvc.
 
Manufacturer Narrative
(b)(4).The customer returned one 3-lumen catheter for evaluation.The catheter body was cut; the separated portion was not returned.The catheter was returned with a saline-filled syringe attached to the medial luer hub.Visual examination of the returned catheter revealed one small cut on the medial extension line adjacent to the juncture hub.Microscopic examination revealed the cut was smooth in appearance.The extension line also contained adhesive residue.The appearance of the cut was consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc).The medial extension line was cut 18 mm from the juncture hub.The returned catheter body measured to be 85 mm, indicating that at least 73.5 mm were separated and not returned per product drawing.With the distal end of the catheter body occluded, water was injected into the all three extension lines using a lab inventory 10ml syringe.When water was injected into the medial extension line, water exited the cut.Functional testing of the distal and proximal extension lines did not reveal any leaks.A manual tug test confirmed the luer hubs were secure on the extension lines.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit cautions the user, "to minimize the risk of cutting catheter, do not use scissors to remove dressing." the customer report of the extension line leaking in use was confirmed through visual/functional inspection of the returned sample.Functional leak testing of the extension line revealed a small cut in the extension line.The edges of the cut were smooth and the appearance was consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc).A device history record review did not reveal any manufacturing related issues.Based on the condition of the returned sample, 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
It was reported that the nurse could not aspirate and get blood return and it felt like sucking air.The nurse takes away the three-way stopcock and aspirate directly from the catheters blue extension.The user gets a blood return but when injects saline some blood comes through the blue extension on the cvc.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7935726
MDR Text Key122806495
Report Number3006425876-2018-00644
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Catalogue NumberCS-12853
Device Lot Number71F18E1270
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Date Manufacturer Received10/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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