MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC KIT: 1L 4.5FR 55CM AGBA TIPTRACK; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45541-TTS
Medical Device Problem Codes	Break (1069); Material Separation (1562); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the clinician had difficulty peeling the sheath apart.One tab broke off after pulling so hard.No patient harm was reported and the picc was successfully placed.The sheath was removed from the patient in its entirety.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a peel-away tab breaking was able to be confirmed by the photo.A device history record review was performed, and two relevant findings were identified.Two non-conformances were initiated to address the issue of a peel-away tearing incorrectly.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 tab separating was confirmed through complaint investigation of the customer supplied photo.Visual analysis revealed that one of the tabs separated 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.
Event or Problem Description
It was reported the clinician had difficulty peeling the sheath apart.One tab broke off after pulling so hard.No patient harm was reported and the picc was successfully placed.The sheath was removed from the patient in its entirety.The patient's condition is reported as fine.

• Brand Name: ARROW PI PICC KIT: 1L 4.5FR 55CM AGBA TIPTRACK
• 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: 17904579
• Report Number: 9680794-2023-00763
• Device Sequence Number: 12818373
• Product Code: LJS
• UDI-Device Identifier: 30801902125379
• UDI-Public: 30801902125379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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 Catalogue Number: CDC-45541-TTS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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