MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CV-42703

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Cardiac Arrest (1762); Reaction (2414)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information received: the resuscitation was successful following the cardiac arrest.The patient did not have a history of an allergy to chlorhexidine.The patient recovered well and surgical procedure was performed at a later date.

Event Description

It was reported that "anaphylactic shock to chlorhexidine impregnation on the line.Severe anaphylaxis, cardiac arrest required resuscitation, itu admission.Confirmed anaphylaxis to chlorhexidine with allergy testing".

Manufacturer Narrative

(b)(4).The sample was not returned; however, the customer did provide two photos for evaluation.One photo was of the components inside the kit and the other photo was of the lidstock.No other defects or anomalies could be observed from the customer photos.A dhr review was performed based on the lot number from the lidstock in the customer provided photos.No manufacturing issues were identified.The ifu provided with this kit warns the user "if adverse reactions occur after catheter placement, remove catheter immediately." the report of a catheter related allergic reaction was confirmed through the customer description of the events that occurred.A dhr was performed based on the lidstock in the customer provided photo.The customer stated that a chlorohexidine coated catheter was used during this procedure and it was confirmed that the patient suffered from an allergic reaction to chlorohexidine.Therefore, unintentional user error (patient condition) caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "anaphylactic shock to chlorhexidine impregnation on the line.Severe anaphylaxis, cardiac arrest required resuscitation, itu admission.Confirmed anaphylaxis to chlorhexidine with allergy testing".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9172684
• MDR Text Key: 161721484
• Report Number: 3006425876-2019-00755
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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 Operator: Health Professional
• Device Catalogue Number: CV-42703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention