MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN030925

Device Problem Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product (catalog# cv-22854-sr) is not intended for sale in the us.Similar product/component sold in the us.Two mdrs (two patients involved): 3006425876-2020-00538.

Event Description

It was reported that the central lines inserted in theatre have been leaking through a couple of lumens, when the patients (two patients) have been in ccu.This has also happened when they have been locked.A new device was inserted.

Event Description

It was reported that the central lines inserted in theatre have been leaking through a couple of lumens, when the patients (two patients) have been in ccu.This has also happened when they have been locked.A new device was inserted.

Manufacturer Narrative

(b)(4).The actual device was not returned; however the customer did send eight (8) unopened cv-22854-sr representative kits from six (6) different lots.Two kits were opened and visually examined.No defects or anomalies were detected.The total lengths of both representative catheters measured to be 170 mm which is within specifications of 157-177 mm per product drawing.The representative catheters were initially flushed using a lab inventory syringe.No leaks or blockages were detected.The catheters were then connected to a leak tester and tested per amrq-000071 rev.11 (bs en iso 10555-1 annex c).The requirement states that no liquid leakage shall occur in the form of a falling drop of water when pressurized to 300kpa for 30 seconds.The distal ends of the catheters were clamped and the leak tester was pressurized to 300kpa and held for 30 seconds.No leaks were detected.The returned guide wires were able to pass through the returned catheters with minimal resistance.A device history record review was performed on the reported lot with no relevant findings.The instructions-for-use provided with this kit cautions the user, "use of a syringe smaller than 10 ml to irrigate or declot an occluded catheter may cause intraluminal leakage or catheter rupture." the ifu also cautions, "indwelling catheters should be routinely inspected for desired fl ow rate, security of dressing, correct catheter position and for secure luer-lock connection.Use centimeter markings to identify if the catheter position has changed." the customer report of an extension line leak could not be confirmed by complaint investigation of the returned samples.The returned representative samples passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.The probable cause could not be determined without the actual sample to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10178438
• MDR Text Key: 195900674
• Report Number: 3006425876-2020-00537
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2021
• Device Model Number: IPN030925
• Device Catalogue Number: CV-22854-SR
• Device Lot Number: 71F19G1607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other