MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problem Migration (4003)

Patient Problems Extravasation (1842); Swelling/ Edema (4577)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "involved a cvc device cs-15853 or cv-12853 : the medical team morning team observed a leakage of infusion around the catheter puncture point with diffusion to the shoulder, front of the chest and neck.Doctor decided to remove the device.Opinion taken from a resuscitator doctor, he requested a x-ray.He found that the device was defective.The fixation system has slid along the catheter (the catheter was only about 2 - 3 cm under the skin instead of a much longer length usually)." the clinical consequence was reported as "subcutaneous leakage of infusions (parenteral nutrition + kcl)".The catheter had been placed in the subclavian for 8 days.The patient experienced edema and extravasation with diffusion to shoulder, front thorax and neck.No medical intervention was required.The patient was reported to be "fine" and back home.

Manufacturer Narrative

(b)(4).The customer provided one image for analysis.The photo shows the catheter extrusion with box clamp attached.The customer also returned one catheter extrusion and box clamp for analysis.Signs of use in the form of biological material were observed on the catheter body.Visual analysis of the catheter revealed that the box clamp assembly was returned and attached to the catheter body.It was observed that the box clamp was located towards the distal end of the catheter body.No damage, defects or anomalies were observed with the catheter or box clamp.The proximal portion of the catheter, including the juncture hub and extension lines, was severed and not returned for analysis.It cannot be determined if the catheter was secured via sutures to the catheter body juncture hub (primary site) or the box clamp (secondary site) or both.The material number could not be confirmed; therefore, the inspections were performed according to both provided finished goods cv-12853 and cs-15853 (identical diameter catheters of different lengths).The clamp and fastener components are the same in both reported finished goods.The catheter length measured 153mm, which is not within the specification limits of 158.5mm - 175mm/208.5mm - 225mm per either catheter product drawing.This indicates that the entire catheter was not returned for analysis.The catheter outer diameter measured 2.942mm, which is within the specifications of 2.85mm - 2.95mm per both catheter extrusion product drawings.The clamp catheter inner diameter measured 0.108", which is within the specifications of 0.108" - 0.116" per the catheter product drawing.The inner diameter of the clamp fastener measured 0.177", which is within the specification limits of 0.167" - 0.177" per the clamp fastener product drawing.The box clamp was attached to the catheter body.To test the axial clamp holding force, the box clamp assembly was then attached to a force gauge.Per amrq-000145 rev04, generation 1 combinations of the clamp/fastener for catheters greater than 7fr should sustain a withdrawal force of = 6n (1.35 lbs).The box clamp assembly was pulled in direction of the catheter body to 1.35 lbs.No movement of the clamp was observed.A device history record review was performed based on two potential lots based on sales history of two different reported finished goods (cs-15853 and cv-12853).No relevant findings were identified to suggest a manufacturing related issue.The ifu provided with both kits inform the user, "use catheter hub as primary securement site.Use catheter clamp and fastener as a secondary securement site as necessary.A cath eter clamp and fastener are used to secure catheter when an additional securement site other than the catheter hub is required for catheter stabilization." the customer report of a catheter migration could not be confirmed through complaint investigation of the returned sample.A separated distal portion of the catheter body was returned with the box clamp secured to the catheter body; however, no determination could be made about whether the catheter was secured using primary, secondary or both securement sites.Functional testing confirmed no movement on the box clamp assembly.Inspection of the juncture hub could not be performed as it was not returned for analysis.It could not be determined if the box clamp or the juncture hub suture wings were secured.Therefore, the probable cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that "involved a cvc device cs-15853 or cv-12853 : the medical team morning team observed a leakage of infusion around the catheter puncture point with diffusion to the shoulder, front of the chest and neck.Doctor decided to remove the device.Opinion taken from a resuscitator doctor, he requested a x-ray.He found that the device was defective.The fixation system has slid along the catheter (the catheter was only about 2 - 3 cm under the skin instead of a much longer length usually)." the clinical consequence was reported as "subcutaneous leakage of infusions (parenteral nutrition + kcl)".The catheter had been placed in the subclavian for 8 days.The patient experienced edema and extravasation with diffusion to shoulder, front thorax and neck.No medical intervention was required.The patient was reported to be "fine" and back home.

• Brand Name: ARROW CVC SET: 3-LUMEN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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
• MDR Report Key: 17493203
• MDR Text Key: 321719138
• Report Number: 3006425876-2023-00726
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• 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
• Patient Sequence Number: 1
• Treatment: PARENTERAL NUTRITION + KCL; PARENTERAL NUTRITION + KCL