MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM); CATHETER INTRAVASCULAR THERAPE

Catalog Number	ASK-12703-PSPH1
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-l cvc for evaluation.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection revealed the distal extension line was stretched/ballooned directly adjacent to the luer hub.The observed damage appears consistent with unintentional over pressurization of the extension line during use.After failing functional testing, large amounts of biological material were also observed within the distal end of the catheter.The stretched portion of the extension line measured 1-17mm from the luer hub.The distal extension line outer diameter in a non-stretched area measured 0.085" which is within the specifications of 0.084" - 0.088" per product drawing.The distal extension line inner diameter within the luer hub measured 0.059" which is within the specifications of 0.055" - 0.059" per product drawing.Functional inspection was performed per the instructions for use which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal extension line was flushed using a lab inventory 10ml syringe.A blockage in the form of biological material was identified within the distal extension line, which likely contributed to the over pressurization of the line.After the blockage was removed, the distal extension line flushed as intended.A device history record review was performed with no relevant findings.The ifu provided with this kit informs the user, "warning: ensure patency of each lumen of catheter prior to pressure injection to minimize the risk of catheter failure and/or patient complications.".The customer report of a stretched/ballooned extension line was confirmed through complaint investigation of the returned sample.Visual inspection revealed the distal extension line was partially stretched/ballooned.Functional inspection revealed large amounts of biological material within the distal lumen causing a blockage, which likely contributed to the over pressurization of the line during use.Despite this, the catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error (overpressure) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: "when the nurse attempted to aspirate one of the lumens for the catheter, it collapsed upon itself.Then when attempting to flush the same lumen, part of the extension line ballooned out.Catheter was removed & vascular access was maintained by (2) pivs.There was no patient harm or consequence.".

• Brand Name: ARROW PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19937880
• Report Number: 9680794-2024-00742
• Device Sequence Number: 4876336
• Product Code: FOZ
• UDI-Device Identifier: 10801902214338
• UDI-Public: (01)10801902214338(11)240214(17)250930(10)33F24A0683(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: 09/30/2025
• Device Catalogue Number: ASK-12703-PSPH1
• Device Lot Number: 33F24A0683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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.
• Patient Sex: Unknown