MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 110 IN 15 DROP IV ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9968
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of a yellow substance being found on the spike of the drip chamber was received from the customer.No product or photo was returned by the customer.The customer complaint of foreign matter could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mx9968 because a lot number was not provided by the customer.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.Investigation conclusion: no product will be returned per customer.No investigation was performed.
Event or Problem Description
It was reported that the 110 in 15 drop iv administration set experienced foreign matter in fluid pathway.The following information was provided by the initial reporter: iv tubing package opened and upon examination it was found to have a yellow substance on the sterile puncture piece above the drip chamber.

• Brand Name: 110 IN 15 DROP IV ADMINISTRATION SET
• 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
• MDR Report Key: 12264651
• Report Number: 9616066-2021-51690
• Device Sequence Number: 4225551
• Product Code: FPA
• UDI-Device Identifier: 50885403237803
• UDI-Public: 50885403237803
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/07/2021

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
• Operator of Device: Other
• Device Model Number: MX9968
• Device Catalogue Number: MX9968
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1