MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CS-12122-F

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported "in icu, the doctor found the swg kinked during use on the patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) the report of a kinked guide wire could not be confirmed through examination of the returned sample.The customer returned an opened hemodialysis kit including one guide wire within its advancer, an arrow raulerson syringe (ars), and 18ga introducer needle for evaluation.The guide wire was returned within the advancer tube and signs of use were observed on the guide wire and its assembly.No defects or anomalies were observed on the returned guide wire.The guidewire passed the dimensional and functional test specifications.A device history record review did not identify any manufacturing related issues.Based on the customer description and the sample received, no problem was found on the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "in icu, the doctor found the swg kinked during use on the patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19202430
• MDR Text Key: 341357531
• Report Number: 3006425876-2024-00395
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: 00801902100108
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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 Catalogue Number: CS-12122-F
• Device Lot Number: 71F21J1163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED