MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 2L: 5.5FR X 15CM; MIDLINE CATHETER

Catalog Number	PR-41552-BAS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: when attempting to separate the sheath using the plastic tabs at the top of the sheath the two halves did not separate.One of the plastic tabs broke and a sterile forceps was needed to separate the sheath.This was successful and the procedure was completed.There was no patient injury or consequence.
Event or Problem Description
It was reported that: when attempting to separate the sheath using the plastic tabs at the top of the sheath the two halves did not separate.One of the plastic tabs broke and a sterile forceps was needed to separate the sheath.This was successful and the procedure was completed.There was no patient injury or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).The report that a peel-away tabs broke off was confirmed through complaint investigation.Visual analysis revealed that the sheath was separated directly adjacent to the hub.Despite the damage, the sheath met all relevant dimensional requirements.Based on the customer report, the sample received, and the comments from r & d/mfg, manufacturing caused or contributed to this event.A device history record review was performed, and relevant findings were identified.For eb-01052-002 with batch 34c22c0032, investigations were created regarding peel away sheath extrusion defects.An investigation was initiated to further investigate the issue.The investigation is still on-going.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PI MIDLINE 2L: 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18020690
• Report Number: 9680794-2023-00809
• Device Sequence Number: 6585729
• Product Code: PND
• UDI-Device Identifier: 10801902136586
• UDI-Public: 10801902136586
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Device Expiration Date: 03/29/2024
• Device Catalogue Number: PR-41552-BAS
• Device Lot Number: 13F22K0731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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