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

Catalog Number CS-27702-E

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Swelling (2091); Skin Inflammation (2443)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).Patient condition reported as fine.Additional information states no allergic reaction.

Event Description

It was reported that on (b)(6) 2020, repeated fever, local redness and swelling around the catheter, body temperature up to 38.2, considering the possibility of catheter-related adverse reactions.The central venous catheter was removed on (b)(6) 2020, and the patient had normal body temperature, no adverse fluctuations.

Event Description

It was reported that on 30 jun 2020, repeated fever, local redness and swelling around the catheter, body temperature up to 38.2, considering the possibility of catheter-related adverse reactions.The central venous catheter was removed on 02 july 2020, and the patient had normal body temperature, no adverse fluctuations.

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.The instructions-for-use provided with this kit warns the user, "sterile, single use: do not reuse, reprocess or re-sterilize.Reuse of device creates a potential risk of serious injury and/or infection which may lead to death." 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.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10401106
• MDR Text Key: 202704822
• Report Number: 3006425876-2020-00723
• 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: 08/04/2020

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: No Information
• Device Expiration Date: 10/07/2021
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F19J2025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention