MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-45552-RH
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " as the nurse was tearing the sheath, it tore off in her hand.She said it had felt flimsy." 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 returned one peel-away sheath and picc/delta assembly for analysis.No obvious signs of use were observed on the returned components.Visual analysis revealed the peel-away sheath extrusion was separated adjacent to the tab.A portion of the tab was observed to be separated, and remains of the extrusion were still attached.The other tab was intact and remained connected to the sheath extrusion.The sheath extrusion was completely split along the score lines.The overall length of the sheath measured 2 3/4" which is within the specification limits of 2 5/8" - 2 7/8".The outer and inner diameter of the sheath could not be accurately measured due to the condition of the returned sample.Functional inspection could not be performed due to the condition of the returned sample.Additional testing was not required for this complaint investigation.All complaints are trended across product families on a monthly basis; therefor, a separate complaint history review is not required.A device history record review was performed, and there was one potential finding.Non-conformance was initiated in regard to "peel-away sheath tears incorrectly".The failure mode of this complaint is relevant to the non-conformance identified as it is a manufacturing issue.

• Brand Name: ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18770300
• Report Number: 9680794-2024-00116
• Device Sequence Number: 7795350
• Product Code: LJS
• UDI-Device Identifier: 10801902159967
• UDI-Public: 10801902159967
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: ASK-45552-RH
• Device Lot Number: 33F23J0779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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
• Patient Sex: Unknown