MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC G4 STYLET: 2L 5FR X 55CM W BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-35552-VPSB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the sheath "broke at the right side of the hub of sheath introducer, apart from the catheter".The insertion site was the upper arm.The sheath was removed in its entirety, nothing was left behind.No patient harm or injury occurred.
Event or Problem Description
It was reported the sheath "broke at the right side of the hub of sheath introducer, apart from the catheter".The insertion site was the upper arm.The sheath was removed in its entirety, nothing was left behind.No patient harm or injury occurred.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The complaint of a peel-away tab breaking off was confirmed through complaint investigation.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "check peel-away sheath placement by holding sheath in place, twisting dilator hub counterclockwise to release dilator hub from sheath hub , withdraw guidewire and dilator sufficiently to allow blood flow".The report of a peel-away sheath tabs breaking off was confirmed through complaint investigation of the customer supplied photos.Visual analysis revealed that one tab was broken off from the extrusion.Confirmation from manufacturing revealed that this defect needs to be further investigated by the manufacturing facility.Therefore, manufacturing likely caused or contributed to this issue.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 PI PICC G4 STYLET: 2L 5FR X 55CM W BP
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 17703101
• Report Number: 9680794-2023-00634
• Device Sequence Number: 20694529
• Product Code: LJS
• UDI-Device Identifier: 10801902208672
• UDI-Public: 10801902208672
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 01/31/2024
• Device Catalogue Number: DLX-35552-VPSB
• Device Lot Number: 13F22M0103
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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
• Patient Sex: Unknown