MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 25 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-16123-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the dilator tip was bent so that the user could not insert during use.Therefore, a new kit (lot#: unknown) was used instead.No injury to the patient occurred".The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.The customer returned one dilator and the product lidstock for evaluation.Signs-of-use were observed on the dilator.Visual inspection of the dilator revealed the tip was slightly bent.No other defects or anomalies were observed.The dilator total length measured 5 1/2" via calibrated ruler which was within the specifications of 5 1/4"-5 3/4" per product drawing.The dilator outer diameter (od) at the tip measured 0.04985" via calibrated caliper which was within the specifications of 0.047"-0.050" per product drawing.The dilator inner diameter (id) at the tip measured 0.037" via calibrated pin gauge which was within the specifications of 0.036"-0.038" per product drawing.Functional inspection of the dilator was performed per the instructions-for-use (ifu) provided with the kit which states, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin." a lab inventory 0.877mm guide wire was threaded through the dilator with no resistance.The instructions-for-use (ifu) provided with the kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." a device history record review was performed with no relevant findings.Based on these circumstances and the customer report, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the dilator tip was bent so that the user could not insert during use.Therefore, a new kit (lot#: unknown) was used instead.No injury to the patient occurred".The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # udi related data quality updates only.
Event or Problem Description
It was reported that "the dilator tip was bent so that the user could not insert during use.Therefore, a new kit (lot#: unknown) was used instead.No injury to the patient occurred".The patient status is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 25 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: 18401286
• Report Number: 3006425876-2023-01281
• Device Sequence Number: 14146535
• Product Code: DQY
• UDI-Device Identifier: 00801902099679
• UDI-Public: (01)00801902099679(11)220712(17)270630(10)71F22F6827(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/04/2023

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-16123-F
• Device Lot Number: 71F22F6827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/24/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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 Sex: Unknown