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 Insufficient Information (3190)

Patient Problems Reaction (2414); Bronchospasm (2598)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

"during surgery on (b)(6), the patient had bronchospasm shock once the cvc was inserted.Because the acute allergic reaction happened during surgery, the delayed allergic reactions caused by other medication can be ruled out.Therefore, it was suspected that both fentanyl and chlorhexidine of the cvc coating could be the cause of acute bronchospasm shock.Because the patient continued injecting fentanyl on (b)(6) , it was speculated that the coating chlorhexidine of cvc was more likely to be the cause".

Manufacturer Narrative

(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.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

Customer reports: "during surgery on 4th dec, the patient had bronchospasm shock once the cvc was inserted.Because the acute allergic reaction happened during surgery, the delayed allergic reactions caused by other medication can be ruled out.Therefore, it was suspected that both fentanyl and chlorhexidine of the cvc coating could be the cause of acute bronchospasm shock.Because the patient continued injecting fentanyl on 4th-5th dec, it was speculated that the coating chlorhexidine of cvc was more likely to be the cause".

• 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: 9953549
• MDR Text Key: 187538315
• Report Number: 3006425876-2020-00314
• 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: 03/31/2020

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 Expiration Date: 04/07/2021
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F19D1540
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other