MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 112 IN 15 DROP IV ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9128
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that blood backflowed into the 112 in 15 drop iv administration set tubing during the infusion.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "it was reported that blood is backing up into the tubing.".
Additional Manufacturer Narrative
Correction: the lot number was provided by the customer.The following fields have been updated: d.2.Medical device lot#: 20065593.D.4.Medical device expiration date: 2025-06-04.H.4.Device manufacture date: 2020-06-04.Investigation: h.6.One picture was received from the customer which verifies the customer complaint that blood is backing up into the tubing.No product will be returned for investigation.A device history record review for model mx9128 lot number 20065593 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05jun2020.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.H3 other text : see h.10.
Event or Problem Description
It was reported that blood backflowed into the 112 in 15 drop iv administration set tubing during the infusion.This complaint was created to capture the 4th of 4 related incidents.The following information was provided by the initial reporter: "it was reported that blood is backing up into the tubing.".

• Brand Name: 112 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 22244 ; MX 22244
• MDR Report Key: 11087243
• Report Number: 9616066-2020-20662
• Device Sequence Number: 19515849
• Product Code: FPA
• UDI-Device Identifier: 50885403237629
• UDI-Public: 50885403237629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/05/2021

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: Health Professional
• Device Expiration Date: 06/04/2025
• Device Model Number: MX9128
• Device Catalogue Number: MX9128
• Device Lot Number: 20065593
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1