MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM; MIDLINE CATHETER

Model Number IPN037698

Device Problem Material Deformation (2976)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The inserting nurse believed the gap/spacing between the dilator and sheath was larger than normal making it difficult to advance the sheath through the patient's skin.This caused the sheath to "fray and peel back on itself".The nurse was able to advance and insert the catheter without having much of the sheath in the vein.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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

The inserting nurse believed the gap/spacing between the dilator and sheath was larger than normal making it difficult to advance the sheath through the patient's skin.This caused the sheath to "fray and peel back on itself".The nurse was able to advance and insert the catheter without having much of the sheath in the vein.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW AM/AT PI MIDLINE 2-L: 5.5FR 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: 13762807
• MDR Text Key: 287895468
• Report Number: 9680794-2022-00158
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 50801902130162
• UDI-Public: 50801902130162
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: IPN037698
• Device Catalogue Number: CDC-41552-MPK1A
• Device Lot Number: 13F21J0528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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