MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH BASIC 20GAX8CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037867
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported an endurance catheter was retained in the patient's arm.The iv was leaking and the catheter was found not attached to the hub of the device.An x-ray was done and the patient had the catheter lodged in his arm.The patient went to the or and the catheter was successfully removed.There were no complications with the procedure.The patient's current condition was reported to be fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one defective endurance catheter and a tegaderm dressing for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the catheter body was separated directly adjacent to the juncture hub.Microscopic examination confirmed the separation and revealed that the edges were smooth and uniform.Visual analysis could not be performed on the separated portion of the catheter body as it was not returned for analysis.The catheter body length could not be accurately measured as the separated portion was not returned for analysis.The catheter body outer diameter measured.045", which is within the specification limits of.041"-.045" per the catheter body product drawing.The catheter body inner diameter measured.030", which is within the specification limits of.030"-.034" per the catheter body product drawing.A lab inventory syringe filled with water was attached to the returned side arm of the endurance catheter and flushed.No abnormalities were observed as the water exited the point of separation.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".Pressure testing could not be performed due to the severity of the damage.The catheter was sent to wyomissing where the damage was confirmed.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user: "some disinfectants 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"."allow insertion site to dry completely prior to applying dressing"."do not raise the catheter beyond 90 relative to the skin to avoid catheter kinking and damage." the complaint of an endurance catheter cut/torn was confirmed by a complaint investigation of the returned sample.Visual analysis revealed that the catheter body was separated directly adjacent to the juncture hub.A device history record review was performed, and no relevant findings were identified.Due to an increased trend in endurance catheter leaks/separations, a non-conformance has been initiated to further investigate this issue.The root cause has not yet been determined.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported an endurance catheter was retained in the patient's arm.The iv was leaking and the catheter was found not attached to the hub of the device.An x-ray was done and the patient had the catheter lodged in his arm.The patient went to the or and the catheter was successfully removed.There were no complications with the procedure.The patient's current condition was reported to be fine.

• Brand Name: ARROW EXT DWELL CATH BASIC 20GAX8CM
• 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: 15831629
• Report Number: 9680794-2022-00723
• Device Sequence Number: 12031694
• Product Code: FOZ
• UDI-Device Identifier: 10801902133066
• UDI-Public: 10801902133066
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163513
• 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): 10/29/2022

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: 06/30/2024
• Device Model Number: IPN037867
• Device Catalogue Number: EDC-00820-B
• Device Lot Number: 13F22G0461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 11/20/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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