MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-27702
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Low Blood Pressure/ Hypotension (1914); Anaphylactoid / Anaphylaxis (2218)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: (b)(6) 2023, after catheterization in the surgical centre, blood pressure decreased, skin turned red, and allergic shock occurred.After receiving vasoactive drugs and anti-allergic therapy to replenish blood volume, hormone therapy, and other treatments, the patient's vital signs gradually stabilized before undergoing surgery.The vital signs remained stable during the surgery and patient was returned to the ward after the surgery.There was a delay to surgery but patient was reported as good post the procedure.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(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.The instructions for use (ifu) provided with this kit warns the user, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.Remove catheter immediately if adverse reactions occur after catheter placement.Chlorhexidine containing compounds have been used as topical disinfectants since the mid-1970's.An effective antimicrobial agent, chlorhexidine found use in many antiseptic skin creams, mouth rinses, cosmetic products, medical devices and disinfectants used to prepare the skin for a surgical procedure.Note: perform sensitivity testing to confirm allergy to catheter antimicrobial agents, if adverse reaction occurs." the complaint of catheter related allergic reaction could not be confirmed.No sample was returned for investigation.The customer did not report that allergy testing was performed to confirm a chlorhexidine allergy.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.Therefore, 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 that: on (b)(6) 2023, after catheterization in the surgical centre, blood pressure decreased, skin turned red, and allergic shock occurred.After receiving vasoactive drugs and anti-allergic therapy to replenish blood volume, hormone therapy, and other treatments, the patient's vital signs gradually stabilized before undergoing surgery.The vital signs remained stable during the surgery and patient was returned to the ward after the surgery.There was a delay to surgery but patient was reported as good post the procedure.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM
• 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: 18235672
• Report Number: 9680794-2023-00924
• Device Sequence Number: 20566911
• Product Code: FOZ
• UDI-Device Identifier: 10801902099263
• UDI-Public: 10801902099263
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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?: No
• Device Expiration Date: 01/10/2025
• Device Catalogue Number: CA-27702
• Device Lot Number: 33F23D0668
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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
• Patient Sex: Unknown