MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Material Separation (1562)

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

Event Date 10/31/2021

Event Type  malfunction  

Event Description

The complaint is reported as: "the luer-hub (white head) had falling off from catheter." no patient harm reported.The catheter was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

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 catheter body appeared intentionally cut.The separated portion was not returned.The total length of the catheter body measured to be 205 mm indicating that at least 105mm of the catheter body wasn't returned per product drawing.The outer diameter of the distal lumen measured to be 2.18 mm which is within specifications of 2.13-2.21 mm per product drawing.The inner diameter of the distal lumen measured to be 1.4732 mm which is within specifications of 1.42-1.50 mm per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).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 distal and medial lumens were flushed using a water-filled lab inventory syringe.They both flushed as expected.A manual tug test confirmed the distal and medial extension lines were fully secured within the luer hubs.A device history record review was performed with no relevant findings.The 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." 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.

Event Description

The complaint is reported as: "the luer-hub (white head) had falling off from catheter." no patient harm reported.The catheter was replaced.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 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: 12832627
• MDR Text Key: 280941013
• Report Number: 3006425876-2021-01076
• 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
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F21A2046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.