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	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "during the procedure, the nurse accessed the vein and inserted the 4.5 french glide thru peel-away sheath.When she picked up the catheter to insert it through the sheath, she found a double lumen 5.5 french picc included instead of a single lumen picc." a new kit was opened to complete the procedure.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of incorrect catheter was not able to be confirmed by the photo (only the product label was pictured).A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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.Ensure catheter patency prior to use, including prior to pressure injection".The customer report of incorrect catheter could not be confirmed by visual inspection of the customer supplied photo as only the product label was pictured.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: "during the procedure, the nurse accessed the vein and inserted the 4.5 french glide thru peel-away sheath.When she picked up the catheter to insert it through the sheath, she found a double lumen 5.5 french picc included instead of a single lumen picc." a new kit was opened to complete the procedure.No patient harm reported.The patient's condition is reported as fine.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17249723
• Report Number: 9680794-2023-00478
• Device Sequence Number: 4795751
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/25/2023
• 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