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

Catalog Number	DLX-45563-CURVC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "picc was placed on 4/8 and incident occurred on 5/15.The blue extension line hub separated from the extension line where they meet, due to a fracture in the tubing.It appears there is still a small section of tubing inside the hub.It was reported that the line had become caught under the bed rail while staff was moving the patient.The nurse who was present reported that it was not a forceful pull on the line but there was no one else there to confirm this as the vascular access team was not present at the time the damage occurred.The picc was replaced with an over-the-wire technique." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided two photos for analysis.The photos show the separated extension line with the molding remaining within the luer hub.The customer also returned one, 3-lumen picc catheter for analysis.Signs of use were observed.The distal end of the catheter body appeared intentionally severed.Visual and microscopic analysis revealed the medial extension line was separated from the luer hub, and a portion of the extension line was visible within the luer hub.The extension line appeared rough and jagged at the point of separation.This damage is consistent with past manufacturing molding complaints.The outer diameter of the medial extension line measured 0.093", which is within the specification limits of 0.093"-0.097" per medial extension line extrusion product drawing.The inner diameter of the extension line measured 0.058", which is within the specification limits of 0.055"-0.059" per extension line extrusion product drawing.Manufacturing was contacted as a part of this complaint investigation.They stated that the separation of the extension line from the luer hub is consistent with past molding issues; however, the customer report that the extension line was "caught under the bed rail while staff was moving the patient" suggests unintentional use error (undue force) may have caused or contributed to the damage.Due to the possibility that manufacturing contributed to this damage, they will further investigate this issue.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns 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 extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual and microscopic analysis revealed the extension line was separated from the luer hub, and portions of the extension line were visible within the luer hub.The extension line appeared rough and jagged at the point of separation.Manufacturing stated that the separation of the extension line from the luer hub is consistent with past molding issues; however, the customer report that the extension line was "caught under the bed rail while staff was moving the patient" suggests an undue tensile force may have caused or contributed to the damage.Due to the possibility that manufacturing contributed to this damage , they will further investigate this issue.Various factors could contribute to the observed damage to the extension line including the manufacturing molding process and/or unintentional use error; therefore, the root cause is undetermined.A non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "picc was placed on 4/8 and incident occurred on 5/15.The blue extension line hub separated from the extension line where they meet, due to a fracture in the tubing.It appears there is still a small section of tubing inside the hub.It was reported that the line had become caught under the bed rail while staff was moving the patient.The nurse who was present reported that it was not a forceful pull on the line but there was no one else there to confirm this as the vascular access team was not present at the time the damage occurred.The picc was replaced with an over-the-wire technique." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM TCG
• 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: 22165999
• Report Number: 9680794-2025-00473
• Device Sequence Number: 9382992
• Product Code: LJS
• UDI-Device Identifier: 10801902208740
• UDI-Public: (01)10801902208740(11)241219(17)260227(10)33F24L0503(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): 05/15/2025

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: 02/27/2026
• Device Catalogue Number: DLX-45563-CURVC
• Device Lot Number: 33F24L0503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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