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 Insufficient Information (4580)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "one of swg was faulty and cannot used (bent), and then required a new set" the current status of the patient is "unknown" at ths time.The customer has not returned our request for additional information at this time.

Event Description

It was reported "one of swg was faulty and cannot used (bent), and then required a new set" the current status of the patient is "unknown" at ths time.The customer has not returned our request for additional information at this time.

Manufacturer Narrative

(b)(4).The report that the spring wire guide was kinked was confirmed through examination of the returned sample.The customer returned one, opened hemodialysis kit including one swg within its advancer for analysis.The swg cap and straightener tube, components of the swg assembly, were not returned.Signs of use were observed on the returned sample, which according to additional information received from the customer, likely occurred in the clinical setting.Visual analysis confirmed that there was one kink towards the distal j-bend of the guide wire.The distal j-bend was not misshapen and was intact.Microscopic examination confirmed the defect.Both welds were present and were observed to be full and spherical.No other defects or anomalies were observed with the guide wire or tubing.The kink in the guide wire was located 565 mm via calibrated ruler from the proximal tip.The overall length of the guide wire measured 601 mm via calibrated ruler which was within the specification of 596-604 mm per guide wire product drawing.The outer diameter (od) of the guide wire measured 0.841 mm via calibrated micrometer which was within the specification of 0.838-0.877 mm per guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." a manual tug test confirmed both welds were intact.The instructions-for-use (ifu) provided with the kit warns the user, "do not use if package is damaged".A device history record review was performed, and no relevant findings were identified.During full assembly, the kink on the guide wire would have been located within the straightener tube/swg cap during packaging, shipping, and storage, protecting it from damage.However, the end cap and straightener tube were missing from the returned assembly.Based on the customer report and sample received, the potential root cannot be determined as it could not be confirmed when the damage to the guidewire occurred.Teleflex will continue to monitor and trend for complaints of this nature.

• 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: 18707258
• MDR Text Key: 335442513
• Report Number: 3006425876-2024-00116
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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 Operator: Health Professional
• Device Catalogue Number: CS-12122-F
• Device Lot Number: 71F23E0581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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