MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN030168
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: cvc inserted and uneventful.After insertion it was noticed the tip of the dilator was missing.X-rays show that it is still in the patient.At the time of this report the patient had been extubated and doing well.Cvc remained in place.It was unknown if any intervention was planned to remove the device.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that a portion of the dilator tip was separated.Microscopic examination confirmed the damage and revealed white stress marks along the points of separation.The damage appears consistent with damage due to undue force applied during insertion.The dilator body length measured 4" which is within the specification limits of 3 3/4"-4 1/4" per the dilator graphic.The dilator outer diameter measured 3.46mm which is within the specification limits of 3.43mm-3.50mm per the dilator extrusion graphic.The dilator inner diameter at the proximal end measured 1.0414mm which is within the specification limits of 1.020mm-1.090mm per the dilator extrusion graphic.A lab inventory guide wire with a diameter of.032" was inserted through the distal tip of the returned dilator.The guide wire was able to pass as intended.Performed per ifu statement "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a dilator tip separated was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was damaged.A portion of the tip had separated from the extrusion.White stress marks were also observed at the point of separation.The dilator met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report that the defect was observed during use and the appearance of the damage, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: cvc inserted and uneventful.After insertion it was noticed the tip of the dilator was missing.X-rays show that it is still in the patient.At the time of this report the patient had been extubated and doing well.Cvc remained in place.It was unknown if any intervention was planned to remove the device.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 13054450
• Report Number: 3006425876-2021-01178
• Device Sequence Number: 14425008
• Product Code: FOZ
• UDI-Device Identifier: 10801902102345
• UDI-Public: 10801902102345
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K962577
• 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): 12/01/2021

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: 07/01/2022
• Device Model Number: IPN030168
• Device Catalogue Number: CS-25854-E
• Device Lot Number: 71F20J0407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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
• Patient Sex: Unknown