MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVC
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "picc inserter noted crack in peel away sheath upon examination prior to placing removed from sterile field and new peel away sheath used." this was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away assembly and a sticker label for analysis.No obvious signs of use were observed.Visual analysis revealed that one side of the tabs and a small section of the extrusion were partially cracked/split.The opposite side of the sheath was intact.Microscopic examination confirmed the damage.The sheath length measured 2 3/4", which is within the specification limits of 2 5/8"-2 7/8" per the sheath product drawing.The sheath inner diameter at the proximal end measured 0.080", which is within the specification limits of 0.079"-0.084" per the sheath extrusion product drawing.Manufacturing was contacted as part of this complaint investigation.They requested that the peel-away be completely split to check that it is functional.They also agreed that further analysis is needed by their facility.Per the request from manufacturing, the peel-away was split.No defects or anomalies were observed as the sheath split down both score lines.A device history record review was performed, and no relevant findings were identified.The report that the peel-away split prematurely was confirmed through complaint investigation of the returned sample.Visual analysis revealed that one side of the tabs and a small section of the extrusion were partially cracked/split.Based on the customer report, the sample received, and the comments from manufacturing , 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 inserter noted crack in peel away sheath upon examination prior to placing removed from sterile field and new peel away sheath used." this was found prior to use.There was no patient involvement.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR 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: 22018227
• Report Number: 9680794-2025-00437
• Device Sequence Number: 18306706
• Product Code: LJS
• UDI-Device Identifier: 10801902208733
• UDI-Public: (01)10801902208733(11)250218(17)260227(10)33F25A0291(21)
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 05/07/2025

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-45552-CURVC
• Device Lot Number: 33F25A0291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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