MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 22GAX6CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN920648

Device Problem Material Separation (1562)

Patient Problems Infiltration into Tissue (1931); Pain (1994); Foreign Body In Patient (2687)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

Qn # (b)(4).Medwatch report #: mw5117916.

Event Description

It was reported the customer states that 22g 6cm was put in "small vein near radial artery" on approximatley (b)(6) or (b)(6).The user believes potassium was put through the cathter.The patient complained and they noted the catheter infiltrated.Upon removal of catheter they thought a piece of the catheter broke off and an x-ray was taken.A vascular surgeon was called and successfully removed the piece of catheter.The patient was reported to be "fine" and discharged per customer.Medwatch report received states: "on (b)(6) 2023 a six cm long peripheral iv (piv) was inserted at 20:30, and on (b)(6) 2023 at 21:55 the piv was removed due to reported pain at site.When piv removed, only 1 cm remaining.Physicians were notified and exam / diagnostics performed.Surgery performed on (b)(6) 2023 for removal of the retained iv catheter.".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "avoid kinking or obstructing the catheter system during pressure injection to reduce risk of catheter failure.Discontinue pressure injection at first sign of infiltration/extravasation." the ifu also cautions the user "some disinf ectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the customer states that 22g 6cm was put in "small vein near radial artery" on approximatley 5/16 or 5/19.The user believes potassium was put through the cathter.The patient complained and they noted the catheter infiltrated.Upon removal of catheter they thought a piece of the catheter broke off and an x-ray was taken.A vascular surgeon was called and successfully removed the piece of catheter.The patient was reported to be "fine" and discharged per customer.Medwatch report received states: "on (b)(6) 2023 a six cm long peripheral iv (piv) was inserted at 20:30, and on (b)(6) 2023 at 21:55 the piv was removed due to reported pain at site.When piv removed, only 1 cm remaining.Physicians were notified and exam / diagnostics performed.Surgery performed on (b)(6) 2023 for removal of the retained iv catheter.".

• Brand Name: ARROW EXT DWELL CATH DEVICE 22GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17151557
• MDR Text Key: 317542509
• Report Number: 9680794-2023-00412
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902132915
• UDI-Public: 10801902132915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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 Model Number: IPN920648
• Device Catalogue Number: EDC-00622
• Device Lot Number: 14F23A0072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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 Outcome(s): Required Intervention