MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the doctor found the foreign material inside the ars while withdrawing the swg from the ars prior to use on the patient.

Manufacturer Narrative

(b)(4).The customer report of a foreign material observed was confirmed by investigation of the returned sample.The customer supplied photos and video confirmed that there were foreign particulates coming from inside the arrow raulerson syringe (ars) valve.The customer returned an opened cvc kit including an introducer needle, guide wire assembly, and arrow raulerson syringe (ars) for evaluation.Visual inspection revealed that there were no signs of use observed.Further visual analysis of the guide wire assembly and ars revealed foreign particulate inside the needle hub and straightener tube, respectfully.Further analysis revealed that there was a hole in the internal valve of the ars.Microscopic examination confirmed the foreign material inside the needle hub and straightener tube.As per r & d engineering and manufacturing unit, a positive confirmation of the material could not be made based on the appearance of the substance and the small quantity present within the straightener tube and ars handle.Additionally, it could not be confirmed when the particulate was introduced into the kit.A device history record review was performed, and no relevant findings were identified.Based on the appearance of the substance and the small quantity present within the components, a positive confirmation of the material could not be made.Additionally, it cannot be confirmed when the particulate was introduced into the kit.Based on the sample received, comments from r & d, and the complaint investigation, the potential root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that the doctor found the foreign material inside the ars while withdrawing the swg from the ars prior to use on the patient.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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 27560
• MDR Report Key: 17388404
• MDR Text Key: 319744346
• Report Number: 3006425876-2023-00749
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F22H1871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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