MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20D 1CV 2SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Leak/Splash (1354)

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

Event Date 09/05/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch # mw5103830.Device manufacture date: unknown.Investigation summary: a complaint of leakage due to a slice in the tubing was received from the customer.A used sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.There was a cut in the tubing between the second drip chamber and the luer.A device history record review could not be performed because a lot number was not provided by the customer.The root cause for this issue was determined to be an error caused by grippers used in the assembly process.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 gem v/nv 20d 1cv 2ss dehp free was damaged, causing leakage.The following information was provided by the initial reporter: "during the infusion, fluids began leaking and, after examination, a small slit was noted in the tubing, about 1 1/2 inches below the last port.".

• Brand Name: GEM V/NV 20D 1CV 2SS DEHP FREE
• 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: 12653048
• MDR Text Key: 277136809
• Report Number: 9616066-2021-52254
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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