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

Catalog Number	MP5305-C
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter also notified the fda on (date) via medwatch # mw5096907.Investigation summary: no product or photo was returned by the customer.The customer complaint that the maxplus extension set would not flush after multiple attempts could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5305-c lot number 20055016 was performed.The search showed that a total of (b)(4).There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample 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 or Problem Description
It was reported that the 7-in pressure rated set w/ maxplus was clogged/blocked/occluded.The following information was provided by the initial reporter: material #: mp5305-c batch/ lot #: 20055016 maxplus extension set, multiple attempts were made to flush through buff cap on end of extension set (with various from same lot number) and were unable.

• Brand Name: 7-IN PRESSURE RATED SET W/ MAXPLUS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 11092679
• Report Number: 9616066-2020-20686
• Device Sequence Number: 3595897
• Product Code: FPA
• UDI-Device Identifier: 10885403236679
• UDI-Public: 10885403236679
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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
• Operator of Device: Other
• Device Expiration Date: 05/01/2025
• Device Catalogue Number: MP5305-C
• Device Lot Number: 20055016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1