MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that: (b)(6) 2023, the luer hub was found damaged during used to the patient.Patient was reported as fine.

Event Description

It was reported that: (b)(6) 2023, the luer hub was found damaged during used to the patient.Patient was reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "air embolism can occur if air is allowed to enter a vascular access device or vein.Do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Use only securely tightened luer-lock connections with any vascular access device to guard against inadvertent disconnection.".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.

• Brand Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18354350
• MDR Text Key: 330869583
• Report Number: 3006425876-2023-01254
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F22L1544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: NOT REPORTED; NOT REPORTED