MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45563-CURVB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "patient pulled off blue lumen".A new picc was inserted.There was no patient harm or injury.No medical intervention.The patient's current condition "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "patient pulled off blue lumen".A new picc was inserted.There was no patient harm or injury.No medical intervention.The patient's current condition "fine".
Additional Manufacturer Narrative
(b)(4) the customer provided one image showing a 3-lumen picc catheter.Visual analysis revealed that the medial extension line was separated.The separated portion (including the blue luer hub) is not pictured.The customer also returned one, 3-lumen picc catheter for analysis.Signs of use in the form of biological material were observed inside the extension lines.It was noted that the catheter body was severed at the 20cm marking.It is assumed that the body was severed by the customer during catheter trimming prior to insertion.Visual analysis revealed that the medial extension line was separated.The separated portion of the medial line (including the luer hub) was not returned.Microscopic examination confirmed the separation and revealed that the edges were rough/jagged.Additional analysis also revealed indentations that resemble excessive clamping with a needle holder.No other defects or anomalies were observed.The catheter body length measured 21.7cm, which indicates that between 34.15cm-36.06cm of the catheter body was severed and not returned for analysis (per catheter product drawing).The medial extension line outer diameter measured 0.094", which is within the specification limits of 0.093"-0.097" per the medial extension line extrusion product drawing.The medial extension line inner diameter measured 0.056", which is within the specification limits of 0.055"-0.059" per the medial extension line extrusion product drawing.A manual tug test confirmed that the distal and proximal lines appeared secure to their respective luer hubs.Manufacturing and r & d were contacted as part of this complaint.They agreed that additional analysis is needed by the manufacturing facility.A device history record review was performed, and relevant findings were identified.It cannot be verified if the findings are relevant without the separated portion of the extension line also returned.The ifu provided with the kit informs 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 report of a separated extension line was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the medial line luer hub was separated.Further dimensional analysis revealed that the severed line measured within specification.Based on the customer report that the "patient pulled of the blue lumen", the sample received, and the comments from manufacturing, the root cause cannot be determined at this time.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 22203710
• Report Number: 9680794-2025-00493
• Device Sequence Number: 20554838
• Product Code: LJS
• UDI-Device Identifier: 10801902208719
• UDI-Public: (01)10801902208719(11)240528(17)250917(10)33F24C0935(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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 Expiration Date: 09/17/2025
• Device Catalogue Number: DLX-45563-CURVB
• Device Lot Number: 33F24C0935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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; NOT REPORTED
• Patient Sex: Unknown