MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Obstruction of Flow (2423)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported "the luer-hub (brown) was blocked".The device was replaced.No patient harm.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "the luer-hub (brown) was blocked".The device was replaced.No patient harm.The patient's condition is reported as fine.

Event Description

It was reported "the luer-hub (brown) was blocked".The device was replaced.No patient harm.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen cvc for evaluation.The catheter contained obvious signs of use in the form of biological material.Tape/bandages were returned on the extension lines and the distal luer contained a piece of tape over it.Visual inspection did not reveal any defects or anomalies.No obvious kinks or blockages were observed.The total length of the returned catheter body measured to be 216 mm which is within specifications of 207-227 mm per product drawing.The instructions for use provided with this kit instructs the user, "flush lumen(s) to completely clear blood from catheter." all three lumens were flushed using a water-filled lab inventory syringe.The proximal and medial lumens flushed as expected.The distal lumen was unable to flush.A guide wire was advanced through the returned catheter and a significant amount of biological material exited the distal tip.The distal lumen was again flushed and functioned as intended.A device history record review was performed, and no relevant findings were identified.The instructions for use provided with this kit instructs the user, "flush lumen(s) to completely clear blood from catheter." the report of a blocked extension line was confirmed through complaint investigation.Visual and functional analysis revealed that a build-up of biological material had become lodged inside the distal extension line.Once cleared of biological material, all three extension lines functioned as intended.The catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14593789
• MDR Text Key: 293281369
• Report Number: 3006425876-2022-00512
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• 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,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F21G0847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• 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