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

Model Number	IPN036445
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Medwatch received reports "central line ballooned out while it was inserted in the patient".Additional information was requested but was not available at the time of this report.
Event or Problem Description
Medwatch received reports "central line ballooned out while it was inserted in the patient".Additional information was requested but was not received at the time of this report.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-l cvc catheter for evaluation.Signs of use in the form of biological material were present on the catheter body and in the extension lines.Visual inspection of the distal extension line confirmed the line was stretched.There was a clear transition point in the extension line where the line began to stretch and balloon.The damage is consistent with the line being over-pressurized.The total length of the catheter body measured 215 mm, which is within specifications of 207-227 mm per catheter product drawing.The inner diameter of the distal extension line at the undamaged portion measured 0.055", which is within specifications of 0.055-0.059" per distal extrusion graphic.The outer diameter of the distal extension line at the undamaged portion measured 0.08510", which is within specifications of 0.084-0.088" per distal extrusion graphic.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all lines were found to be blocked when attempting to flush with a lab inventory syringe.A lab wire was able to pass through the medial and proximal lines and clear the biological material.A blockage was found within the juncture hub of the distal line.The blockage was cleared with a wire and found to be biological material.A manual tug test confirmed the distal , medial, and proximal lines were secure to their luer hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit warns the user."open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure.Pressure injection procedures must be performed by trained personnel well versed in safe technique and potential complications.Discontinue pressure injections at first sign of extravasation or catheter deformation.Follow institutional policies and procedures for appropriate medical intervention.".The customer complaint of a stretched/ballooned extension line was confirmed by a visual inspection of the returned sample.The distal line of the catheter was found to be stretched out.The damage appeared consistent with the line being over-pressurized.A device history record review was performed based on sales history, and no relevant findings were identified.Based on the customer description that the damage occurred during use, and the sample returned, user error likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 20CM
• 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: 15402317
• Report Number: 9680794-2022-00561
• Device Sequence Number: 5183769
• Product Code: FOZ
• UDI-Device Identifier: 10801902116793
• UDI-Public: 10801902116793
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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 Model Number: IPN036445
• Device Catalogue Number: CDC-15703-P1A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/11/2022
• 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 Age: 41 YR
• Patient Sex: Male
• Patient Weight: 79 KG