MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Model Number IPN919441

Device Problem Device Slipped (1584)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2023

Event Type  malfunction  

Event Description

It was reported that: the catheter slipped out of the catheter clamp when wet.Additional information has been requested from the account.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).The customer returned one unopened cvc kit for analysis, therefore, it is being assumed it is a representative sample.The kit was opened to further analyze the components.Visual analysis of the returned components revealed no obvious defects or anomalies.Based on the customer description, 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 overall length of the catheter measured 217mm which is within the specification limits of 207mm - 227mm per the catheter product drawing.The catheter outer diameter measured 2.479mm which is within the specifications of 2.39mm - 2.49mm per both catheter extrusion product drawing.The clamp catheter inner diameter measured 0.089", which is within the specifications of 0.088" - 0.092" per the catheter product drawing.The inner diameter of the clamp fastener measured 0.176", which is within the specification limits of 0.167" - 0.177" per the clamp fastener product drawing.Functional inspection was performed per the instructions for use (ifu) provided with the kit which states, "use a catheter stabilization device, catheter clamp and fastener, staples or sutures(where provided).Use catheter hub as primary securement site.Use catheter clamp and fastener as a secondary securement site as necessary.".The catheter juncture hub was secured within a vice and the box clamp was attached to the catheter body.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 up to 7fr should sustain a withdrawal force of = 2n (0.44 lbs).The box clamp assembly was pulled in direction of the catheter body to 0.44 lbs.No movement of the clamp was observed.Functional analysis of the actual sample could not be performed as it was not returned.R & d was contacted as a part of this complaint investigation.They stated that both 4-lumen blue catheter clamp (k-25854-003a) and the 3-lumen white catheter clamp (k-14703-013a) are made of the same material.They are made of styrene butadiene which is a type of thermoplastic elastomer.The clamp fastener is composed of a different material, but is included within all kits.Additionally, as per the ifu, they confirmed that the components should be used with a dry catheter.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user , "after guidewire has been removed and necessary lines have been connected or locked, spread wings of rubber clamp and position on catheter making sure catheter is not moist, as required, to maintain proper tip location.".The ifu also states , "ensure insertion site is dry before applying dressing per manufacturer's instructions." the customer report of a catheter migration could not be confirmed through complaint investigation of the returned representative sample.Based on the customer description, 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.R & d was contacted, and they confirmed that the catheter body is intended to be dry as per the ifu.Based on the circumstances, and without the reported sample returned for analysis, 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: the catheter slipped out of the catheter clamp when wet.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• 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: 17985002
• MDR Text Key: 326584504
• Report Number: 3006425876-2023-01002
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN919441
• Device Catalogue Number: EU-15703-CVT
• Device Lot Number: 71F22L0116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Female