MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Model Number IPN037697

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported the introducer had a bend and then started to buckle up.Patient was reported to have saggy thin skin.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of sheath body damaged in use was able to be confirmed by the photo.The photo revealed damage to the sheath as reported.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, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." 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 Description

It was reported the introducer had a bend and then started to buckle up.Patient was reported to have saggy thin skin.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
• Type of Device: MIDLINE 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: 16327749
• MDR Text Key: 309187647
• Report Number: 9680794-2023-00060
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 50801902130155
• UDI-Public: 50801902130155
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2024
• Device Model Number: IPN037697
• Device Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 13F22K0456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Sex: Female