MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-25802-E

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Anaphylactic Shock (1703)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "after cvc insertion, patient had severe anaphylactic shock reaction.It was suspected that it was caused by the coating on cvc.After cpr, patient's vitals were stabilized.Surgery was delayed.Patient was conscious after awoke from the anesthesia and was transferred to sicu for observation." the patient's condition was reported as critical.At the time of this report the patient remained in icu.

Manufacturer Narrative

Qn# (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 antimicrobial catheter technology information card provided with this kit states, "use of the arrowg+ard blue antimicrobial catheter technology is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." the card also states , "perform sensitivity testing to confirm allergy to catheter antimicrobial agents, if adverse reaction occurs." it was not reported if sensitivity testing was performed.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "after cvc insertion, patient had severe anaphylactic shock reaction.It was suspected that it was caused by the coating on cvc.After cpr, patient's vitals were stabilized.Surgery was delayed.Patient was conscious after awoke from the anesthesia and was transferred to sicu for observation." the patient's condition was reported as critical.At the time of this report the patient remained in icu.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 20 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11805078
• MDR Text Key: 249953120
• Report Number: 3006425876-2021-00401
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/10/2022
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F20D0278
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 44 YR