MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4L 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-45703-P1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the catheter was placed on (b)(6) 2023 and on (b)(6) 2023 the lumen separated."primary rn entered patient's room in response to bed-fall alarm.Patient was ambulating to restroom at that time.Primary rn assisted patient to restroom.It was noted that patient's iv tubing was no longer connected to his cvc.It is unclear what caused the line to fail.Upon assessing his iv line, it was noted that the lumen with heparin infusion had broken.Patient's central line was assessed by primary rn, charge rn, and resource rn.Tubing found to be broken apart in such a way that it cannot be repaired or reconnected.Tubing was clamped, and exposed tubing was covered with a sterile dressing and antimicrobial cap." the catheter was removed.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(6).The customer report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.The customer returned one 3-l cvc for analysis.Signs-of-use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter revealed the proximal luer hub separated directly adjacent to the extension line.Remains of the extension line molding were visible inside the separated luer hub.Microscopic examination confirmed the damage.The extension line appeared rough and jagged at the point of separation.The catheter body length from the juncture hub to the distal end measured 214mm via calibrated ruler which was within the specifications of 207-227mm per product drawing.The proximal extension line outer diameter (od) measured 0.0859" via calibrated caliper which was within the specifications of 0.084"-0.088" per product drawing.The proximal extension line inner diameter (id) measured 0.058" via calibrated pin gauge which was within the specifications of 0.055"-0.059" per product drawing.This indicated that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the medial and distal extension lines were flushed using a lab inventory 10ml syringe.No leaks or blockages were observed.Functional inspection of the proximal extension line could not be performed due to the damage.A manual tug test confirmed the distal and medial luer hubs were secured to their respective extension lines.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." a device history record review could not be performed as no lot number was provided and a potential lot could not be identified from sales history.Based on these circumstances, manufacturing likely caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the catheter was placed on (b)(6) 2023 the lumen separated."primary rn entered patient's room in response to bed-fall alarm.Patient was ambulating to restroom at that time.Primary rn assisted patient to restroom.It was noted that patient's iv tubing was no longer connected to his cvc.It is unclear what caused the line to fail.Upon assessing his iv line, it was noted that the lumen with heparin infusion had broken.Patient's central line was assessed by primary rn, charge rn, and resource rn.Tubing found to be broken apart in such a way that it cannot be repaired or reconnected.Tubing was clamped, and exposed tubing was covered with a sterile dressing and antimicrobial cap." the catheter was removed.

• Brand Name: ARROW PI CVC KIT: 4L 8.5 FR X 20 CM
• Common Device Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17904177
• Report Number: 9680794-2023-00736
• Device Sequence Number: 7635475
• Product Code: FOZ
• UDI-Device Identifier: 30801902117275
• UDI-Public: 30801902117275
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: CA-45703-P1A
• Device Lot Number: A008914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown