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 Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Vomiting (2144); Urticaria (2278); Swelling/ Edema (4577)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the patient threw up during the device placement in the right neck.After finishing the placement of the device, patient showed right eye swelling and urticaria on the whole body, and was difficult to breathe as well.Therapist used drug "vena, solu-cortef" and removed the catheter." it was reported the physician removed the catheter and the patient recovered.No additional medical intervention was performed.

Manufacturer Narrative

(b)(4).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.The ifu provided with the kit informs the user, "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".The contradications label included with this finished 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".The medical director of clinical and medical affairs was contacted as part of this complaint investigation.He confirmed that a g6pd testing does not confirm a chlorhexidine allergy.Therefore, it is still unknown if the customer has an allergy to chlorhexidine.The customer report of an allergic reaction was not able to be confirmed by the event details of the reported complaint.It was not confirmed if the patient has a hypersensitivity to chlorhexidine.Chlorhexidine is included in the coating of the catheter in this kit.Based on the customer report and the comments from clinical medical affairs, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for complaints of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint is reported as: "the patient threw up during the device placement in the right neck.After finishing the placement of the device, patient showed right eye swelling and urticaria on the whole body, and was difficult to breathe as well.Therapist used drug "vena, solu-cortef" and removed the catheter." it was reported the physician removed the catheter and the patient recovered.No additional medical intervention was performed.

• 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: 16799643
• MDR Text Key: 313865666
• Report Number: 3006425876-2023-00389
• 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: 03/30/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F22H2298
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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
• Treatment: MEDICATION FOR DIABETES (UNKNOWN).; MEDICATION FOR DIABETES (UNKNOWN).
• Patient Outcome(s): Required Intervention