MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-17702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the catheter was bent after the doctor inserted and pulled it out, cannot perform again.No patient harm.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).Additional information states that the "dilator" was bent, not the catheter as stated in the initial report.The report of a damaged dilator body was confirmed through complaint investigation.Visual analysis revealed that the distal portion of the dilator body contained a continuous bend and the distal tip additionally appeared damaged.Despite the damage, the dilator met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the defect was observed "during use" and the sample received, 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
It was reported that: the catheter was bent after the doctor inserted and pulled it out, cannot perform again.No patient harm.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only** other remarks: n/a, corrected data: n/a.
Event or Problem Description
It was reported that: the catheter was bent after the doctor inserted and pulled it out, cannot perform again.No patient harm.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18356159
• Report Number: 3006425876-2023-01261
• Device Sequence Number: 12368776
• Product Code: DQY
• UDI-Device Identifier: 00801902104960
• UDI-Public: (01)00801902104960(11)211021(17)260930(10)71F21K1345(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2023

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: 09/30/2026
• Device Catalogue Number: CS-17702-E
• Device Lot Number: 71F21K1345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/10/2024; Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/11/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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 Sex: Unknown