MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SMALLBORE 6 INCH EXT VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number 20039E

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 08/08/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Fda notified: the initial reporter also notified the fda via medwatch #: (b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint that the product did not flush could not be verified due to the product not being returned for failure investigation.A device history record review for model 20039e lot number 21055555 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12may2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no product will be returned per customer.No investigation was performed.

Event Description

It was reported that the smallbore 6 inch ext vlv experienced flow issues, and was clogged.The following information was provided by the initial reporter: describe the event or problem- when starting an iv the iv would not flush, after taking out the iv, it was noted the j loop did not flush.

• Brand Name: SMALLBORE 6 INCH EXT VLV
• 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: 12488892
• MDR Text Key: 271957071
• Report Number: 9616066-2021-52073
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013820
• UDI-Public: 27613203013820
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 08/24/2021

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 Operator: Other
• Device Model Number: 20039E
• Device Catalogue Number: 20039E
• Device Lot Number: 21055555
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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