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

Model Number	IPN033013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11329742
• Report Number: 3006425876-2021-00137
• Device Sequence Number: 11428184
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: 30801902124310
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN033013
• Device Catalogue Number: CS-12402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMOFKABIVEN; SMOFKABIVEN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 MO