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

Catalog Number	CDC-41541-MPKC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the plastic on sheath broke apart incorrectly causing line to come out and procedure to be repeated.The issue was identified during use on patient but there was no reported patient harm or consequence.
Event or Problem Description
It was reported that: the plastic on sheath broke apart incorrectly causing line to come out and procedure to be repeated.The issue was identified during use on patient but there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The report that a peel-away did not tear correctly was confirmed through complaint investigation of the returned sample.The customer returned one peel-away sheath for analysis.Signs-of-use in the form of biological material was observed.Visual analysis revealed that one of the tabs did not tear correctly.This resulted in the extru-sion to separate.Further analysis revealed that one side of the sheath was split completely separated down the entire extrusion.The sheath body length from the tabs to the distal tip measured 2 13/16" via calibrated ruler, which was within the specification limits of 2 5/8"-2 7/8" per the peel-away product drawing.The sheath outer diam-eter/inner diameter could not be accurately measured as the sheath was completely split.R & d confirmed that the failure for this com-plaint was consistent with an extrusion defect.The ifu provided with the kit informs the user, "do not use excessive force when introduc-ing guidewire, peel-away sheath over tissue dilator, or tissue dila-tor as this can lead to vessel perforation and bleeding, or component damage".A device history record review was performed, and five rele-vant findings were identified for which further investigations were initiated to address the issue of a peel-away tearing incorrectly.Based on the customer report, the sample received, and the comments from r & d, manufacturing caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17938178
• Report Number: 9680794-2023-00766
• Device Sequence Number: 2971909
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: 10801902205435
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 12/31/2024
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F23D0743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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
• Patient Sex: Unknown