MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number CDA-42703-P1A

Device Problem Material Separation (1562)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

It was reported the proximal port broke off of the triple lumen central line.The lumen was locked at the time of the incident.The device was removed and replaced on (b)(6) 2022.It was reported there was no patient injury and the patient's condition was fine.After catheter replacement the patient subsequently developed symptoms of fever, worsened tachycardia, increased vasopressor requirements overnight leading to blood cultures and regimen of antibiotics.It was unclear if the symptoms were related to catheter reinsertion.Additional information was requested but was not available at the time of this report.

Manufacturer Narrative

(b)(4).

Event Description

It was reported the proximal port broke off of the triple lumen central line.The lumen was locked at the time of the incident.The device was removed and replaced on (b)(6) 2022.It was reported there was no patient injury and the patient's condition was fine.After catheter replacement the patient subsequently developed symptoms of fever, worsened tachycardia, increased vasopressor requirements overnight leading to blood clutures and regimen of antibiotics.It was unclear if the symptoms were related to catheter reinsertion.

Manufacturer Narrative

Qn# (b)(4).Additional information was requested regarding a central line infection that was caused by the hub separation.The customer response indicates "i don't believe a line infection was ever diagnosed or was suspected".The customer returned one 3-l cvc for evaluation.Signs of use were observed on the catheter and extension lines.Visual inspection of the catheter revealed the proximal extension line separated directly adjacent to luer hub.Portions of the molding were still visible inside the luer hub.The extension line appeared stretched at the point of separation, and the separation edge was rough and jagged.The catheter body total length measured 168mm which is within the specifications of 157-177mm per the catheter product drawing.The proximal extension line outer diameter measured 0.08541" which is within the specifications of 0.084-0.088" per proximal extension line extrusion drawing.The proximal extension line outer diameter measured 0.057" which is within the specifications of 0.055-0.059" per proximal extension line extrusion drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which states "flush each lumen with sterile saline solution to establish patency and prime lumen (s)." the distal and medial extension lines were flushed using a lab inventory 5cc syringe.Both extension lines flushed as expected.No leaks or blockages were observed.A manual tug test confirmed the distal and medial extension lines were secure to their respective luer hubs.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.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray 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 catheter 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 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.The catheter met all relevant dimensional/functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14622747
• MDR Text Key: 293526862
• Report Number: 9680794-2022-00359
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• 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: 05/18/2022

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 Expiration Date: 09/30/2023
• Device Catalogue Number: CDA-42703-P1A
• Device Lot Number: 13F22A0958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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