MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported patient suffered anaphylaxis caused by the coating material on the catheter, and "cause harm to the patient".The suspected material is (b)(6).It was reported the treatment was the physician immediately removed the catheter and placed a non -antibacterial catheter with continuous physiological monitoring.The patient's condition was reported to be critical.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported patient suffered anaphylaxis caused by the coating material on the catheter, and "cause harm to the patient".The suspected material is chlrohexidine.It was reported the treatment was the physician immediately removed the catheter and placed a non -antibacterial catheter with continuous physiological monitoring.The patient's condition was reported to be critical.

Event Description

It was reported patient suffered anaphylaxis caused by the coating material on the catheter, and "cause harm to the patient".The suspected material is chlrohexidine.It was reported the treatment was the physician immediately removed the catheter and placed a non -antibacterial catheter with continuous physiological monitoring.The patient's condition was reported to be critical.

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 product lidstock provided with the kit informs the user, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs (refer to product instructions for references)".The customer report of an allergic reaction could not be confirmed by the event details and without the sample returned.It is unknown if the patient had a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.Based on the information provided, the root cause cannot be determined as it is unknown if the customer had a specific allergy that caused the reaction.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 13500834
• MDR Text Key: 285405037
• Report Number: 3006425876-2022-00140
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

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 Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F21B0858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention