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 Code	Foreign Body In Patient (2687)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Nurse noticed the line was not flushing correctly 2 days after insertion.The nurse did not remove the line.The nurse left the line in for another 2-3 days.The nurse pulled the line to discontinue.Upon removal, the hub of the catheter came out, with the catheter left dwelling and remaining in the patient.The patient had to go to the operating room to remove foreign body.
Additional Manufacturer Narrative
Qn# (b)(4).Medwatch report # mw5116607 received.
Additional Manufacturer Narrative
(b)(4).Medwatch report # mw5116607 received.Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Nurse noticed the line was not flushing correctly 2 days after insertion.The nurse did not remove the line.The nurse left the line in for another 2-3 days.The nurse pulled the line to discontinue.Upon removal, the hub of the catheter came out, with the catheter left dwelling and remaining in the patient.The patient had to go to the or to remove foreign body.

• 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: 16857581
• Report Number: 9680794-2023-00304
• Device Sequence Number: 3428809
• Product Code: FOZ
• UDI-Device Identifier: 10801902196368
• UDI-Public: 10801902196368
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: IPN920647
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F22L0070
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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: ANTIBIOTIC ADMINISTRATION.; ANTIBIOTIC ADMINISTRATION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown