MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2260-0500

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problem Chemical Exposure (2570)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown device manufacture date: unknown investigation summary: the customer reported an issue of leakage with bd infusion set of material 2260-0500.This complaint was captured using information provided by health canada¿s medical devices online databases.No photos or samples were provided and without further information.A device history record review could not be performed because a lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the complaint cannot be verified and the root cause of this failure remains unknown.

Event Description

It was reported that as lvp 20d low sorb leaked.The following information was provided by the initial reporter: material split, cut or torn and fluid leak.

• Brand Name: AS LVP 20D LOW SORB
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 12330485
• MDR Text Key: 266846233
• Report Number: 9616066-2021-51805
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: 07613203012591
• Combination Product (y/n): N
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2260-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other