MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-34052-HPHNM
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during operating process, the peel-away sheath was broken when tear off." another set was used to complete the procedure.No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "during operating process, the peel-away sheath was broken when tear off." another set was used to complete the procedure.No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.Visual inspection of the customer photo revealed that one of the tabs did not tear down the extrusion correctly, resulting in it to separate.The extrusion was additionally separated into various other pieces, each of which were not torn along the score lines, indicating that the sheath didn't tear as intended.Therefore, the complaint of a sheath tearing incorrectly was able to be confirmed by the photo.Dimensional and functional inspections could not be performed as no sample was returned for analysis.A device history record review was performed, and a relevant finding was identified.Non-conformance was created for batch regarding peel-away sheath tears incorrectly.The customer report of a sheath tearing incorrectly was confirmed through inspection of the customer photo.Visual analysis revealed that the sheath split incorrectly along the score lines.Therefore, based on the customer report and photo, manufacturing caused or contributed to this event.Non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected to (b)(4).

• Brand Name: ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19352881
• Report Number: 9680794-2024-00490
• Device Sequence Number: 7431426
• Product Code: LJS
• UDI-Device Identifier: 00801902100979
• UDI-Public: 00801902100979
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 05/31/2025
• Device Catalogue Number: PR-34052-HPHNM
• Device Lot Number: 33F23C0667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown