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

Catalog Number PR-41552-BAS

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 327331439
• Report Number: 9680794-2023-00809
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 10801902136586
• UDI-Public: 10801902136586
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED