MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Model Number IPN033013

Device Problem Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The complaint is reported as: a catheter was inserted in the right jugular on (b)(6) 2020 at 7 pm.On (b)(6) 2020 it was observed that it caused an extravasation of product "smofkabiven".The patient was found on (b)(6) 2020 at around 8 am with an edema of the right cheek extending to his neck.The catheter remained inserted and held by threads.The infusion was stopped and the doctor was called.The doctor decided to apply g30% % (glucose 30%) compresses and to have a new catheter inserted.Thus, on (b)(6) at 4:30 pm the patient returned to the operating room and a new catheter was inserted in left jugular.The edema and pain disappeared 3 days after insertion of the new catheter.The patient's condition was reported to be fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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

The complaint is reported as: a catheter was inserted in the right jugular on (b)(6) 2020 at 7 pm.On (b)(6) 2020 it was observed that it caused an extravasation of product "smofkabiven".The patient was found on (b)(6) 2020 at around 8 am with an edema of the right cheek extending to his neck.The catheter remained inserted and held by threads.The infusion was stopped and the doctor was called.The doctor decided to apply g30% % (glucose 30%) compresses and to have a new catheter inserted.Thus, on (b)(6) at 4:30 pm the patient returned to the operating room and a new catheter was inserted in left jugular.The edema and pain disappeared 3 days after insertion of the new catheter.The patient's condition was reported to be fine.

• Brand Name: CVC SET: 2-LUMEN 4 FR X 5 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11329742
• MDR Text Key: 232759653
• Report Number: 3006425876-2021-00137
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: 30801902124310
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN033013
• Device Catalogue Number: CS-12402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMOFKABIVEN; SMOFKABIVEN
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO