MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45541-CURVC
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn (b)(4).
Event or Problem Description
It was reported that: patient came to ed with picc in place with complaint of leaking from extension line.Tubing noted to be possibly cut or separated? additional information: the line was being managed and accessed by home health who may have accidentally cut the line while changing the dressing.The patient went to ed and part of the extension line was missing.The line was removed and replaced in ed.
Additional Manufacturer Narrative
(b)(4).The customer returned one, single lumen picc catheter for analysis.Signs of use in the form of biological material were observed.It was noted that the catheter body was intentionally severed at the 50cm marking.The severed portion was not returned.Visual analysis revealed that the distal extension line was severed 0.5cm from the juncture hub.The severed extension line was not returned for analysis.Microscopic examination confirmed the separation and revealed that the edges were smooth and uniform.This is damage consistent with contact with sharps; however, the nature of the separation cannot be confirmed without the severed portion of the extension line also returned.The distal line was severed 5mm from the juncture hub.The distal line outer diameter measured 0.0945", which is within the specification limits of 0.0930"-0.0970" per the distal extension line product drawing.The distal extension line inner diameter measured 0.056", which is within the specification limits of 0.055"-0.059" per the distal extension line product drawing.Dimensional analysis could not be performed on the severed portion of the extension line as it was not returned.Functional analysis could not be performed due to the severity of the damage.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The report of a separated extension line was confirmed through complaint investigation.Visual analysis revealed that the extension line was severed towards the juncture hub; however, the severed portion was not returned.The line met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the observed damage appears consistent with contact with a sharp object during use; however, the nature of the separation cannot be confirmed without the severed portion of the extension line also returned.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: patient came to ed with picc in place with complaint of leaking from extension line.Tubing noted to be possibly cut or separated? additional information: the line was being managed and accessed by home health who may have accidentally cut the line while changing the dressing.The patient went to ed and part of the extension line was missing.The line was removed and replaced in ed.

• Brand Name: AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG
• 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: 18847157
• Report Number: 9680794-2024-00173
• Device Sequence Number: 7860913
• Product Code: LJS
• UDI-Device Identifier: 10801902208726
• UDI-Public: 10801902208726
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2025
• Device Catalogue Number: DLX-45541-CURVC
• Device Lot Number: 33F23G0488
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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