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

Model Number MS3500-15

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a complaint of a set coming without a cap on the spike was received from the customer.A photo was provided by the customer for investigation.Through visual inspection, it was observed that there was no cap on the spike.A device history record review for model ms3500-15 lot number 21063215 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not 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.

Event Description

It was reported that the bd alaris¿ secondary set spike cap was missing.The following information was provided by the initial reporter: "noticed after opening tubing package, cap on spike was missing.".

• Brand Name: BD ALARIS¿ SECONDARY 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: 12470969
• MDR Text Key: 271377690
• Report Number: 9616066-2021-52042
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: 50885403222618
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Device Lot Number: 21063215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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