MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 17 INCH EXT SET W/.2MF & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number 20350E

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: actual lot number is unknown, however the customer suspects lots 21039655 (mfg: 03/09/2021/exp: 03/12/2024).Investigation summary: a complaint of kinks found on set, as well as the tubing being discolored, was received from the customer.A photo was provided for the investigation of this defect.In the photo it was observed that the tubing was discolored near the filter.The customer complaint was confirmed.A device history record review for the model and lot number was performed.There was 1 quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined as a physical sample was not provided for investigation.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 three 17 inch ext set w/.2mf & vlv port had kinked tubing.The following information was provided by the initial reporter: "it has occurred 3 separate times with different patients (2) that we know of.If you look at the taped areas, those are the areas where the tubing was kinking and the nurses were trying to stabilize.".

• Brand Name: 17 INCH EXT SET W/.2MF & VLV PORT
• 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: 12384010
• MDR Text Key: 268684377
• Report Number: 9616066-2021-51923
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012264
• UDI-Public: 37613203012264
• 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: 08/04/2021

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: 20350E
• Device Catalogue Number: 20350E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/30/2021
• 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