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

Model Number	IPN920648
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Pain (1994); Foreign Body In Patient (2687)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).Medwatch report #: mw5117916.
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9680794-2023-00412
• Device Sequence Number: 3929105
• Product Code: FOZ
• UDI-Device Identifier: 10801902132915
• UDI-Public: 10801902132915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown