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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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.No patient injury reported.No medical intervention required.It was reported "there was no consequence for the patient because he was monitored with arterial catheters" and "the team was quickly to help the patient".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unopened representative kit and one 3-lumen cvc for evaluation.The cvc was returned with open slide clamps on all three lumens.Visual examination did not reveal any kinks, depressions, or damage to the extension lines.Visual examination of the representative sample did not reveal any defects or anomalies.The outer diameter of the proximal lumen measured to be 2.14 mm which is within specifications of 2.13-2.21 mm per product drawing.The inner diameter of the proximal lumen measured to be 1.42 mm which is within specifications of 1.42-1.50 mm per product drawing.This indicates that the wall thickness measured within specifications.The sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all three lumens were flushed using a water-filled lab inventory syringe.No blockages or leaks were detected.The ifu also instructs, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." a lab inventory guide wire was able to pass through the returned catheter with minimal resistance.The returned extension lines were repeatedly clamped and unclamped.No depressions or blockages were observed after clamping.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "slide clamp(s) are provided on extension lines to occlude flow through each lumen during line and luer-lock connector changes." the customer report of damaged/compressed extension lines could not be confirmed by complaint investigation of the returned sample and representative kit.The catheter passed all relevant visual , dimensional, and functional testing, and a device history record review was performed with no relevant findings.No issues were observed.Teleflex will continue to monitor and trend for complaints of this nature.
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.No patient injury reported.No medical intervention required.It was reported "there was no consequence for the patient because he was monitored with arterial catheters" and "the team was quickly to help the patient.".

• 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: 11368937
• Report Number: 3006425876-2021-00178
• Device Sequence Number: 3444132
• 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): 02/09/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/29/2021
• 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: AMINO ACIDS; AMINO ACIDS