MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0500

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one unused primary set, model 2426-0500, was received by the customer for investigation.Upon visual inspection, it could be observed that the set's middle smartsite needleless connector was disconnected from the tubing.No other defects were observed.The customer's complaint that when tubing was removed from packaging, the item was disconnected at a y site was verified.A device history record review for model 2426-0500 lot number 19125907 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Visual inspection under magnification was performed on both the internal and external tubing engagement components.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: it could be identified that the solvent had not been properly applied to the tubing during the assembly process.

Event Description

It was reported that a as lvp 20d dehp 3ss cv experienced component separation before use.The following was reported by the initial reporter: when tubing was removed from packaging, the item was disconnected at a y site.

• Brand Name: AS LVP 20D DEHP 3SS CV
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12063627
• MDR Text Key: 264839654
• Report Number: 9616066-2021-51395
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2021

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: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 21033145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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