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

Catalog Number CS-25703-E

Device Problem Material Separation (1562)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "the lure -lock connection (white head) had falling off after using 2 to 5 days".No patient harm reported.The device was removed and replaced.The patient's condition is reported as fine.

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

The complaint is reported as: "the lure -lock connection (white head) had falling off after using 2 to 5 days".No patient harm reported.The device was removed and replaced.The patient's condition is reported as fine.

Event Description

The complaint is reported as: "the lure -lock connection (white head) had falling off after using 2 to 5 days".No patient harm reported.The device was removed and replaced.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen cvc for investigation.Visual inspection revealed the proximal extension line was separated directly adjacent to the luer hub.Remains of the extension line were found inside the luer hub.The points of separation were rough and jagged.The total length of the catheter body measured to be 219 mm which is within specifications of 207mm - 227mm per product drawing.The outer diameter of the proximal lumen measured to be 2.18 mm which is within specifications of 2.13mm - 2.21mm per product drawing.The inner diameter of the proximal lumen measured to be 1.47mm which is within specifications of 1.42mm-1.50mm per product drawing.This indicates that the wall thickness measured within specifications.The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the medial and distal lumens were flushed using a water-filled lab inventory syringe.The distal lumen flushed as expected.When the medial lumen was flushed, biological material exited the lumen.The medial extension line was flushed again and this time, it flushed as expected.No blockages or leaks were observed.Functional inspection could not be performed on the proximal extension line since the luer hub was separated.A manual tug test confirmed the distal and medial extension lines were fully secured within the luer hubs.A manual tug test could not be performed on the proximal extension line since the luer hub was separated.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the report of an extension line/luer hub separation was confirmed through the complaint investigation.Visual analysis revealed that the proximal extension line had separated adjacent to the luer hub.It was noted that remains of the extension line were found within the luer hub.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The root cause of this issue has not yet been determined.Teleflex will continue to monitor and trend complaints 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 INC.; reading PA
• 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: 12328426
• MDR Text Key: 266870248
• Report Number: 3006425876-2021-00735
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/25/2022
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F20M0391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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.; NOT REPORTED.