MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN055199
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer reports "the clamp is making a mark that decreases the flow of the infusion of the treatment delivered to the patient.".It was reported when clamping the proximal line (white cap), the plastic is compressed and remains compressed, preventing the infusion of amino acids.The issue was observed during the discontinuation of norepinephrine and the patient experienced hypotension.It was reported no medical intervention was required and there was no consequence for the patient's health as "close monitoring performed has limited hypotension and hypertension on the amino acids infusion line".To solve the issue the user "attached the catheter before and after the connections".
Event or Problem Description
Customer reports "the clamp is making a mark that decreases the flow of the infusion of the treatment delivered to the patient.".It was reported when clamping the proximal line (white cap), the plastic is compressed and remains compressed, preventing the infusion of amino acids.The issue was observed during the discontinuation of norepinephrine and the patient experienced hypotension.It was reported no medical intervention was required and there was no consequence for the patient's health as "close monitoring performed has limited hypotension and hypertension on the amino acids infusion line".To solve the issue the user "attached the catheter before and after the connections".
Additional 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.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11368877
• Report Number: 3006425876-2021-00180
• Device Sequence Number: 3444131
• Product Code: DQY
• UDI-Device Identifier: 10801902146615
• UDI-Public: 10801902146615
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: IPN055199
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F20H2580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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: NOREPINEPHRINEAMINO ACIDS; NOREPINEPHRINEAMINO ACIDS