MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN037257
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the cvc was placed in a patient.The clinician stood patient up and hub (port) "popped off." clinicians clamped off the catheter and successfully removed it from the patient without incident.No patient harm was reported.A new catheter was placed.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: the cvc was placed in a patient.The clinician stood patient up and hub (port) "popped off".Clinicians clamped off the catheter and successfully removed it from the patient without incident.No patient harm was reported.A new catheter was placed.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4), the customer provided three photos for analysis.The first two images show the product lidstock, with the material and lot numbers displayed.The third image shows a clamped distal extension line with a missing luer hub.Therefore, the issue of an extension line/luer hub separation can be confirmed by the provided photo.The customer also returned one 3-l catheter for analysis.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter revealed the distal luer hub separated from the distal extension line.The distal luer hub was not returned.The extension line separation point was rough and jagged.Without the distal luer hub, the location of the extension line separation cannot be determined.The catheter length measured 217mm, which is within the specifications of 207-227mm per product drawing.The distal extension line outer diameter measured 0.08439", which is within the specifications of 0.084"-0.088" per product drawing.The distal extension line inner diameter measured 0.057" which is within the specifications of 0.055"-0.059" per product drawing.This indicates that the wall thickness measured within specification.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 proximal extension lines were flushed using a lab inventory 10ml syringe to test for leaks or blockages.Both extension lines flushed normally.No leaks or blockages were observed.Functional inspection of the distal extension line could not be performed due to the damage.A manual tug test confirmed the medial and proximal extension lines were fully secured onto 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 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 customer report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual inspection revealed the distal luer hub separated from the extension line.The luer hub was not returned.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Without the complete sample returned for analysis, the probable root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 15821466
• Report Number: 9680794-2022-00727
• Device Sequence Number: 6109015
• Product Code: FOZ
• UDI-Device Identifier: 10801902114058
• UDI-Public: 10801902114058
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: IPN037257
• Device Catalogue Number: ASK-45703-PUKL
• Device Lot Number: 13F22D0357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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