MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI MIDLINE 1L: 4FR X 20CM; MIDLINE CATHETER

Catalog Number	CDC-32041-MPKC
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the midline insertion, the peel-away sheath over dilator would not twist and engage completely.The procedure was continued, with the dilator/sheath not fully locked together.The catheter was placed successfully.The condition of the patient is reported to be 'fine' and the patient had no harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one sheath and dilator for analysis.Definite signs of use were observed on the returned components.Visual analysis of the components revealed that the sheath tabs were separated and the extrusion was completely torn down the score lines.This is consistent with the user report that the sheath was used despite the identification of the defect in the component interaction.Microscopic examination of the sheath tabs and dilator hub revealed no obvious defects or anomalies.The overall length of the sheath measured 2 3/4" which is within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The overall length of the dilator measured 3 3/4" which is within the specification limits of 3 5/8 - 3 7/8" per the dilator product drawing.The outer diameter of the dilator measured 0.060" which is within the specification limits of 0.059 - 0.061" per the dilator product drawing.The returned dilator was advanced through a lab inventory peel-away sheath and the hub was locked into the sheath tabs.The dilator was able to advance lock as intended.Performed per ifu provided with this kit "ensure dilator is in position and locked to hub of sheath.".Functional inspection of the locking functionality of the sheath could not be performed due to the condition of the returned sample.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user , "ensure dilator is in position and locked to hub of sheath".The customer report of difficulty to lock the dilator into the sheath could not be confirmed based on the investigation of the returned sample.The peel-away sheath was returned completely peeled with the sheath tabs separated, and the extrusion completely torn down the score lines.The sheath and dilator passed all relevant dimensional requirements, and the dilator passed functional testing with a lab inventory sheath.The sheath could not be functionally tested due to the destructive nature of the device usage.A device history record review revealed no relevant findings.Therefore, based on the customer report and the sample received, the potential root cause could not be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that during the midline insertion, the peel-away sheath over dilator would not twist and engage completely.The procedure was continued, with the dilator/sheath not fully locked together.The catheter was placed successfully.The condition of the patient is reported to be 'fine' and the patient had no harm or injury.

• Brand Name: ARROW PI MIDLINE 1L: 4FR X 20CM
• 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: 21091483
• Report Number: 9680794-2025-00025
• Device Sequence Number: 8775685
• Product Code: PND
• UDI-Device Identifier: 10801902216820
• UDI-Public: (01)10801902216820(11)240412(17)251130(10)33F24B0530(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K213855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 11/30/2025
• Device Catalogue Number: CDC-32041-MPKC
• Device Lot Number: 33F24B0530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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