MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 20GAX6CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN920647
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported after unsuccessful attempt in the left anterior forearm for an ultrasound placed iv, upon removal part of the catheter remained under the skin.The piece of catheter was removed (method unknown) and another catheter was placed successfully.It was reported the patient experienced pain.
Additional Manufacturer Narrative
(b)(4).The customer provided four photos showing a defective endurance catheter and a lidstock for analysis.Visual analysis revealed that the catheter body was separated adjacent to the 6cm marking.The separated portion of the separation is not pictured.The customer also returned one endurance catheter and a lidstock for analysis.No definite signs of use were observed.The separated portion of the catheter was not returned for analysis.Visual analysis revealed that the catheter body was separated adjacent to the 6cm marking.Microscopic examination confirmed the damage and revealed that the edges of the separation were smooth and angled.Visual analysis could not be performed on the separated portion as it was not returned for analysis.The point of separation on the catheter body measured 55mm from the juncture hub.The catheter body outer diameter measured 0.0420", which is within the specification limits of 0.041"-0.045" per the catheter extrusion product drawing.The catheter extrusion inner diameter at the point of separation measured 0.032", which is within the specification limits of 0.030"-0.034" per the catheter extrusion product drawing.The catheter body was flushed with a lab inventory syringe filled with water.No leaks or blockages were encountered as the water exited the point of separation on the catheter body.Performed per ifu statement, "engage extension line clamp and remove the vent plug from catheter extension line luer hub, attach a 10 ml syringe filled with normal saline for injection, unclamp and check for brisk free-flowing blood return, flush, and reengage extension line clamp".R & d was contacted as part of this complaint investigation.They indicated that the pattern of the separation is consistent with damage due to contact with sharps (i.E.The needle bevel).A device history record review was performed, and no relevant findings were observed to suggest a manufacturing related issue.The ifu provided with the kit instructs the user on proper technique for inserting the catheter and cautions the user: "do not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage." the report of a cut endurance catheter was confirmed through complaint investigation.Visual analysis revealed that the catheter body was separated adjacent to the 6cm marking.Microscopic examination revealed that the edges of the separation were smooth, angled and appeared consistent with contact with the needle bevel during an attempted insertion.Additionally, the catheter met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings to suggest a manufacturing related issue.Based on the customer report, the sample received, and the comments from r & d, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported after unsuccessful attempt in the left anterior forearm for an ultrasound placed iv, upon removal part of the catheter remained under the skin.The piece of catheter was removed (method unknown) and another catheter was placed successfully.It was reported the patient experienced pain.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX6CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16616714
• Report Number: 9680794-2023-00211
• Device Sequence Number: 6272454
• Product Code: FOZ
• UDI-Device Identifier: 10801902196368
• UDI-Public: 10801902196368
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2023

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 Expiration Date: 07/31/2024
• Device Model Number: IPN920647
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F22G0217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/25/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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