MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 117-IN 20PK; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0500

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: the customer reported an issue of leakage with bd infusion set of material 2420-0500.This complaint was captured using information provided by health (b)(4) medical devices online databases.No photos or samples were provided and without further information, the complaint cannot be verified and the root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced flow issues, and leakage.The patient received unspecified medical intervention with their final outcome being currently unknown.The following information was provided by the initial reporter: hemorrhage/bleeding, unexpected medical intervention, improper flow or infusion, leak / splash.

• Brand Name: GEM V/NV 20DP CKV 2SS 117-IN 20PK
• 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: 12330344
• MDR Text Key: 266838511
• Report Number: 9616066-2021-51800
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: 37613203012448
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/17/2021
• 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): Required Intervention