MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12123-F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "guide wire damaged and not in working condition".No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "guide wire damaged and not in working condition".No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Event or Problem Description
It was reported that "guide wire damaged and not in working condition".No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
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.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 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: 18196263
• Report Number: 3006425876-2023-01136
• Device Sequence Number: 6553997
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: (01)00801902102119(11)221209(17)271130(10)71F22M0101(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2023

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 Catalogue Number: CS-12123-F
• Device Lot Number: 71F22M0101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 12/15/2023; Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/18/2023; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 68 KG