MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25122-F

Device Problem Material Deformation (2976)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the doctor found the dilator tip damaged during use on the patient." a new device was used.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

Event Description

It was reported "the doctor found the dilator tip damaged during use on the patient." a new device was used.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer provided one photo for analysis.The photo shows the distal portion of a dilator; however, visual analysis of the photo could not confirm the damage.The customer also returned one dilator for analysis.No obvious signs of use were observed on the dilator.Visual inspection of the dilator revealed the distal tip appeared deformed.Microscopic examination of the dilator at the distal tip revealed damage within the dilator extrusion.The dilator body length measured 5.4330", which is within the specification limits of 5.2500"-5.7500" per dilator product drawing.The dilator inner diameter at the distal tip measured 0.037" which is within the specification limits of 0.036"-0.038" per dilator product drawing.The dilator was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "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 0.035" guide wire was threaded through the returned dilator and was able to advance through with little to no resistance.The dilator was sent to the manufacturing facility for further investigation.They stated that the damage likely occurred during the manufacturing process; however, the damage on the dilator tip was not able to be detected during their visual inspection.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with this 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." the report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.Visual inspection of the dilator revealed the distal tip appeared deformed and there were signs of damage within the dilator extrusion.The sample was sent to the manufacturing facility for further investigation, and they stated that the damage on the dilator likely occurred during the manufacturing process and was not detected during their visual inspections.Based on the sample received and comments from manufacturing , manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19103110
• MDR Text Key: 340563882
• Report Number: 3006425876-2024-00357
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: 00801902100207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993933
• 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: 03/20/2024

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-25122-F
• Device Lot Number: 71F23F0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/14/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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