MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI MIDLINE 2-L: 5FR X 20CM; MIDLINE CATHETER

Catalog Number	CDC-32052-MPKB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Udi number: (b)(4).
Event or Problem Description
It was reported, "white tabs on glidethru sheath broke off during midline insertion.Procedure completed without any difficulties." the sheath was removed and the procedure was completed.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "white tabs on glidethru sheath broke off during midline insertion.Procedure completed without any difficulties." the sheath was removed and the procedure was completed.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one peel away sheath for analysis.Definite signs of use were observed.Visual analysis revealed that the peel away sheath extrusion was not torn correctly down the extrusion.The sheath tear at the score line appeared scalloped/wavy, which is not its intended appearance.The sheath tab was additionally observed to be separated.Remains of the extrusion was still within the separated tab.The other tab was intact.Only one half of the extrusion was returned for analysis.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 outer and inner diameter 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 customer report of a sheath torn incorrectly was confirmed by visual inspection of the returned sample.The appearance of the sheath extrusion at the score lines was scalloped/wavy, which is not its intended appearance.Therefore, based on the customer report and sample received, the root cause of this event is manufacturing related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW PI MIDLINE 2-L: 5FR 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: 19606203
• Report Number: 9680794-2024-00686
• Device Sequence Number: 12813092
• Product Code: PND
• UDI-Device Identifier: 10801902205404
• UDI-Public: (01)10801902205404(11)231115(17)250531(10)33F23J0809(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/20/2024

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
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: CDC-32052-MPKB
• Device Lot Number: 33F23J0809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown