MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0007

Device Problem Leak/Splash (1354)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo of primary set, model 2426-0007, was received by the customer for investigation.Upon visual inspection, it could be observed that the base of the 2nd smartsite needleless connector had disconnected from the tubing.No other defects were observed.The customer's complaint that the iv tubing separated at the y site was verified.A device history record review for model 2426-0007 lot number 21079235 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Since no physical sample received, an investigation could not be performed and a root cause could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.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: since no physical sample received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the bd alaris¿ pump module administration set experienced component separation.The following information was provided by the initial reporter: iv tubing separated at the y site.

• Brand Name: BD ALARIS¿ PUMP MODULE ADMINISTRATION SET
• 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: 12668621
• MDR Text Key: 277677684
• Report Number: 9616066-2021-52271
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• 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,user facility
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21079235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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