MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 60 CM; CATHETER PERCUTANEOUS

Model Number	IPN914757
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "during canalization of the peripheral central venous catheter, the dilator showed resistance to enter the skin.It could not be done and when removing the dilator, it was observed that the tip was open." no patient harm reported.A new device was obtained for use.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn #(b)(4).The customer did not return a complaint sample; however, they supplied two photos showing a dilator.Visual analysis revealed that the dilator tip was split/frayed.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "use vessel dilator to enlarge site as required.Warning: do not leave vessel dilator in place as an indwelling catheter to minimize the risk of possible vessel wall perforation".The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis of the customer photos revealed that the dilator tip was split/frayed; however, the actual dilator was not returned for analysis.The probable cause of the damage to the dilator tip could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during canalization of the peripheral central venous catheter, the dilator showed resistance to enter the skin.It could not be done and when removing the dilator, it was observed that the tip was open." no patient harm reported.A new device was obtained for use.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 60 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: 12965561
• Report Number: 3006425876-2021-01151
• Device Sequence Number: 17188402
• Product Code: DQY
• UDI-Device Identifier: 10801902158038
• UDI-Public: 10801902158038
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/17/2021

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
• Device Expiration Date: 04/28/2026
• Device Model Number: IPN914757
• Device Catalogue Number: CS-17752
• Device Lot Number: 71F21D2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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 Age: 70 YR
• Patient Sex: Unknown