MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-25802-E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "after anesthesia, the patient was catheterized by right deep vein puncture, and after catheter placement, the patient's invasive arterial blood pressure appeared to drop significantly, from 115/59 mmhg to 52/35 mmhg, and the patient's blood pressure rose with repeated multiple intravenous pushes of epinephrine at 10ug/ml, and subcutaneous injections of epinephrine at 0.3 mg into the left shoulder, and the patient repeatedly developed recurrent intractable hypotension.The catheter was removed and replaced with another brand of deep venous catheter." additional information was requested from the customer, no additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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, "after anesthesia, the patient was catheterized by right deep vein puncture, and after catheter placement, the patient's invasive arterial blood pressure appeared to drop significantly, from 115/59 mmhg to 52/35 mmhg, and the patient's blood pressure rose with repeated multiple intravenous pushes of epinephrine at 10ug/ml, and subcutaneous injections of epinephrine at 0.3 mg into the left shoulder, and the patient repeatedly developed recurrent intractable hypotension.The catheter was removed and replaced with another brand of deep venous catheter." additional information was requested from the customer, no additional information is available at this time.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 20 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20031107
• Report Number: 3006425876-2024-00810
• Device Sequence Number: 16899998
• Product Code: FOZ
• UDI-Device Identifier: 00801902102331
• UDI-Public: (01)00801902102331(11)230911(17)250802(10)71F23J0290(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2025
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F23J0290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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
• Patient Sex: Unknown