MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN055195
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	09/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tion, potassium with serum protein electrophoresis sodium to push syringe (b)(4).
Event or Problem Description
The complaint is reported as: when rinsing one of the lines of the cvc, a bolus of norepinephrine occurred.The patient had a "hemodynamic disorder" with hypertensive surge then hypotensive.The noradrenaline was stopped and the patient was put under oxygen.It was reported the same issue recurred shortly afterwards when hydration was changed on the line for isofundine resulting in a bolus of sodium.After medical intervention and hemodynamic stabilization of the patient, hydration was put on another peripheral line.The noradrenaline was on the medial line at 8mg/40ml.Patient was reported to be fine.
Additional Manufacturer Narrative
Continuation of d11: tion potassium with serum protein electrophoresis sodium to push syringe (b)(4).The customer returned one 3-lumen catheter for investigation.Visual examination revealed all three of the extension lines had a yellow tint.No defects or anomalies were detected.The total length of the returned catheter body measured to be 167 mm which is within specifications of 157-177 mm per product drawing.Functional inspection was performed per the the instructions-for-use (ifu) provided with this kit.The ifu states, "flush lumen(s) to completely clear blood from catheter." all three lumens were flushed using a water-filled lab inventory syringe.No leaks or blockages were detected.When each lumen was flushed, water exited the respective skive location.No issues were detected.The distal tip of the catheter was then clamped.A lab inventory syringe was used to pressurize each lumen.No backflow was observed in any of the extension lines.A lab inventory guide wire (of the same size as the guide wire provided with this kit) was advanced through the distal lumen and exited through the distal tip.No issues were identified.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "using catheters not indicated for high pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." the customer report of inter lumen crossover could not be confirmed through functional testing of the returned sample.The catheter passed all relevant visual, dimensional, and functional testing, and a device history record review was performed and no relevant findings were identified.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The complaint is reported as: when rinsing one of the lines of the cvc, a bolus of norepinehprine occurred.The patient had a "hemodynamic disorder" with hypertensive surge then hypotensive.The noradrenaline was stopped and the patient was put under oxygen.It was reported the same issue recurred shortly afterwards when hydration was changed on the line for isofundine resulting in a bolus of sodium.After medical intervention and hemodynamic stabilization of the patient, hydration was put on another peripheral line.The noradrenaline was on the medial line at 8mg/40ml.Patient was reported to be fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12658179
• Report Number: 3006425876-2021-00965
• Device Sequence Number: 16471305
• Product Code: DQY
• UDI-Device Identifier: 10801902105223
• UDI-Public: 10801902105223
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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 Expiration Date: 02/28/2025
• Device Model Number: IPN055195
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F20K0697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACUPAN WITH SERUM PROTEIN ELECTOPHORESIS AND HYDRA; ACUPAN WITH SERUM PROTEIN ELECTOPHORESIS AND HYDRA; ACUPAN WITH SERUM PROTEIN ELECTOPHORESIS AND HYDRA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown