MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-IN PRESSURE RATED SET W/ MAXPLUS; INTRAVASCULAR ADMINISTRATION SET

Model Number MP5303-C

Device Problem Packaging Problem (3007)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Investigation summary: a complaint of packaging not being fully sealed was received from the customer.Three unopened samples were returned for investigation.Through visual inspection, the customer complaint was confirmed.The packaging on all three samples was partially opened.A device history record review for model mp5303-c lot number 19125699 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06dec2019.There was 1 quality notifications issued for the failure mode reported by the customer during the production build of this set.An investigation was performed by the manufacturing plant.The root cause for this defect was found to be a dirty mold on the manufacturing machinery.To correct the failure mode an fmea activation and control process activation were completed on march 23rd, 2021.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 7-in pressure rated set w/ maxplus packaging seal was open.The following information was provided by the initial reporter: "supplier packaging had an open seal on the side.Qe found during examination of the product.".

• Brand Name: 7-IN PRESSURE RATED SET W/ MAXPLUS
• 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: 12280808
• MDR Text Key: 265168801
• Report Number: 9616066-2021-51708
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403236653
• UDI-Public: 50885403236653
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 07/08/2021

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: MP5303-C
• Device Catalogue Number: MP5303-C
• Device Lot Number: 19125699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• 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