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

Catalog Number	CDC-42703-XPN1A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "extension line ballooning.Query that ir went to pressure inject through line with clamp in place, but ir states that the line was not clamped and everything was working fine prior and during pressure injection".The line was replaced.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "extension line ballooning.Query that ir went to pressure inject through line with clamp in place, but ir states that the line was not clamped and everything was working fine prior and during pressure injection".The line was replaced.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The complaint of an extension line stretched/ballooned was confirmed through visual inspection of the photo.The photo shows a deformed medial extension line, near where the extension line clamp was placed.The customer returned one, 3-l pressure-injectable cvc for evaluation.Signs-of-use were observed on the catheter body and inside the extension lines.The catheter was returned with the medial extension line slide clamp in the open position.Visual inspection of the catheter revealed the medial extension line was stretched/ballooned partway down the extrusion.The damage appears consistent with unintentional over pressurization of the extension line during use.The deformation in the medial extension line was located 0-25mm from the luer hub.The outer diameter of the medial extension line in a non-deformed area measured 0.08549" which is within the specifications of 0.084"-0.088" per product drawing.The inner diameter of the medial extension line could not be accurately measured due to the damage.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provided with the kit which states, "ensure patency of each lumen of catheter prior to pressure injection to minimize the risk of catheter failure and/or patient complications." the catheter lumens were flushed using a lab inventory 10ml syringe.All lumens flushed as expected, with no leaks or blockages observed.The instructions-for-use (ifu) provided with the kit warns the user , "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure.Precaution: pressure limit settings on injector equipment may not prevent over pressurizing an occluded or partially occluded catheter." the customer report of a stretched/ballooned extension line was confirmed through complaint investigation of the complaint sample.Visual inspection revealed the medial extension line was deformed partially down the extrusion.The damage appeared consistent with unintentional over pressurization of the extension line during use.The instructions-for-use (ifu) provided with the kit warns the user, "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure".Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19202020
• Report Number: 9680794-2024-00366
• Device Sequence Number: 7952319
• Product Code: FOZ
• UDI-Device Identifier: 10801902162066
• UDI-Public: 10801902162066
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/01/2024

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
• Device Catalogue Number: CDC-42703-XPN1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Male