MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARROWG+ARD BLUE THREE- LUMEN CVC CATHETE; CATHETER INTRAVASCULAR THERAPE

Catalog Number VASCULAR UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Anaphylactic Shock (1703); Cardiac Arrest (1762)

Event Date 10/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Complaint notification received from health canada reports: "patient had known and documented severe allergy to chlorhexidine with previous anaphylaxis reactions and was admitted to hospital with upper gi bleed.Peripheral iv access tenous and patient required urgent central line placement as was having further melena stools.All measures taken to avoid exposure to chlorhexidine including signage at bedside, removal of any known chlorhexidine products, and use of proviodine for skin preparation.During line suturing, patient began to exhibit signs of analphylaxis (angioedema) resulting in severe anaphylactic reaction immediately after insertion of r ij triple lumen by physician.Patient rec'd immediate im epinephrine 0.5 mg.During this time, patient suffered cardiac arrest with successful resuscitaiton including intubation.Patient was treated with iv epinephrine infusion, solumedrol, benadryl and famotidine and was seen by allergy team to attempt to identify source".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The instructions-for-use (ifu) provided with the kit involved with this complaint is not known as the customer did not report a finished good material#/lot#; however, the standard ifu included with cvc products states the following: "the arrowg+ard blue plus antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine, and/or sulfa drugs." the customer reported that the patient has an allergy to chlorhexidine, which is included within the coating of many types of teleflex catheters; however, without the finished good material#/lot#, the complaint could not be confirmed as it is unknown if the catheter involved contains chlorhexidine coating.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Complaint notification received from health canada reports: "patient had known and documented severe allergy to chlorhexidine with previous anaphylaxis reactions and was admitted to hospital with upper gi bleed.Peripheral iv access tenous and patient required urgent central line placement as was having further melena stools.All measures taken to avoid exposure to chlorhexidine including signage at bedside, removal of any known chlorhexidine products, and use of proviodine for skin preparation.During line suturing, patient began to exhibit signs of analphylaxis (angioedema) resulting in severe anaphylactic reaction immediately after insertion of r ij triple lumen by physician.Patient rec'd immediate im epinephrine 0.5 mg.During this time, patient suffered cardiac arrest with successful resuscitaiton including intubation.Patient was treated with iv epinephrine infusion, solumedrol, benadryl and famotidine and was seen by allergy team to attempt to identify source".

• Brand Name: ARROW ARROWG+ARD BLUE THREE- LUMEN CVC CATHETE
• Type of Device: 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: 15652900
• MDR Text Key: 302209216
• Report Number: 9680794-2022-00693
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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?: No
• Device Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PERIPHERAL IV; PERIPHERAL IV
• Patient Outcome(s): Life Threatening; Required Intervention