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

Model Number	IPN037698
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9680794-2022-00158
• Device Sequence Number: 5749952
• Product Code: PND
• UDI-Device Identifier: 50801902130162
• UDI-Public: 50801902130162
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• 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): 02/21/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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
• Patient Sex: Unknown