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

Catalog Number CS-47702-E

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "(b)(6) year old male pt had anaphylactic reaction following insertion of cvc impregnated line.No prior allergies to chlorhexidine noted.Pt intubated once vitals stable and procedure completed as planned.Further allergy testing undertaken and confirmed chlorhexidine allergy recorded." no additional information available at the time of this report.

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 provided with this kit states, "the arrowg+ard blue plus antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." the ifu also states, "perform sensitivity testing to confirm allergy to catheter antimicrobial agents , if adverse reaction occurs." the customer report of an allergic reaction was confirmed by the event details of the reported complaint.The patient had an allergic reaction and later was confirmed to have a chlorhexidine allergy.Chlorhexidine is included in the coating of the catheter in this kit.Based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The complaint is reported as: "61 year old male pt had anaphylactic reaction following insertion of cvc impregnated line.No prior allergies to chlorhexidine noted.Pt intubated once vitals stable and procedure completed as planned.Further allergy testing undertaken and confirmed chlorhexidine allergy recorded." no additional information available at the time of this report.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12213782
• MDR Text Key: 263105133
• Report Number: 3006425876-2021-00666
• 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: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CS-47702-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention