MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 1L 4.5 FR X 55 CM VPS; INTRODUCER, CATHETER

Model Number	IPN911881
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: upon opening the kit, the nurse found a double lumen picc included instead of a single lumen picc.Another kit had to be opened.The issue was found prior to use on patient.No patient involvement.
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported that: upon opening the kit, the nurse found a double lumen picc included instead of a single lumen picc.Another kit had to be opened.The issue was found prior to use on patient.No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of an incorrect catheter was confirmed by visual inspection of the customer supplied photo.The customer provided one photo for analysis and the complaint of an incorrect catheter was able to be confirmed by the photo.A 2-l catheter is shown over a 1-l catheter lidstock.A complete visual inspection could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "read all package insert warnings, precautions and instructions prior to use.Failure to do so may result in severe patient injury or death." a device history record review was performed, and no relevant findings were identified.Based on the available information and the customer photo, packaging likely caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PICC KIT: 1L 4.5 FR X 55 CM VPS
• Common Device Name: INTRODUCER, CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17107668
• Report Number: 9680794-2023-00398
• Device Sequence Number: 2834062
• Product Code: DYB
• UDI-Device Identifier: 10801902134988
• UDI-Public: 10801902134988
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: IPN911881
• Device Catalogue Number: ASK-45541-VFH
• Device Lot Number: 13F22M0093
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown