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

Model Number IPN030925

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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): 3006425876-2020-00537; 3006425876-2020-00538.

Event Description

The customer reports that the extension lumens were blocked during use.A new device was inserted.

Manufacturer Narrative

(b)(4).The customer returned 8 unopened cv-22854-sr representative kits from 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 the lab leak tester and tested.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 flow 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 sample.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 samples to evaluate.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the extension lumens were blocked during use.A new device was inserted.

• 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: 10178555
• MDR Text Key: 196060544
• Report Number: 3006425876-2020-00538
• 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

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1