MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC SET 2-L: 5.5 FR X 50 CM; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-45052-HP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "upon opening the packaging of the 5.5 fr picc catheter, it was observed that part of the guide support was broken, and upon removing the guide, it was found to be broken in the same area.A different picc was used to carry out the procedure".This was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4) the customer provided three photos for analysis.The photos show a kinked guidewire assembly and the kit lidstock.The customer also returned one opened (b)(4) hp kit set for analysis.No signs of use were observed.The returned guidewire assembly was kinked.The guidewire was kinked towards the center which aligned with the kink in the protective tube.The guidewire was also kinked at the distal end.Microscopic examination confirmed the kinks in the guidewire body and guidewire assembly.Both welds were present and were observed to be full and spherical.The product lidstock states, "do not use if package has been previously opened or damaged." no other defects or anomalies were observed on the returned guide wire assembly.The kinks on the guide wire measured at 25 and 205 mm from the distal tip.The guide wire length measured 454 mm, which is within the specification limits of 449.2-458.8 mm per guide wire product drawing.The guide wire outer diameter measured 0.440 mm, which is within the specification limits of 0.432-0.457 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "raise thumb and pull arrow advancer approximately 4 - 8 cm away from introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into needle to further advance guidewire.Continue until guidewire reaches desired depth." the guide wire was advanced through a lab inventory ars to functionally test the guide wire.The undamaged portions of the guide wire passed through with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The product lidstock states, "do not use if package has been previously opened or damaged." the ifu provided with this kit warns the user, "do not use if package is damaged." the customer report of a kinked guidewire assembly was confirmed through complaint investigation of the returned sample.Kinking was observed on the guidewire body which aligned with kink in the guidewire assembly.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report that the defect was observed prior to use and the sample received, storage and shipping likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "upon opening the packaging of the 5.5 fr picc catheter, it was observed that part of the guide support was broken, and upon removing the guide, it was found to be broken in the same area.A different picc was used to carry out the procedure".This was found prior to use.There was no patient involvement.

• Brand Name: ARROW AM PICC SET 2-L: 5.5 FR X 50 CM
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 23278149
• Report Number: 9680794-2025-00835
• Device Sequence Number: 12975327
• Product Code: LJS
• UDI-Device Identifier: 10801902095722
• UDI-Public: (01)10801902095722(11)240626(17)260118(10)14F24F0126(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 01/18/2026
• Device Catalogue Number: PR-45052-HP
• Device Lot Number: 14F24F0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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