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

Model Number	10012144
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.It was reported that the secondary bag contents backed up into the primary bag.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 10012144 lot number 20035092 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04mar2020.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 bd alaris infusion set experienced flow issues.The following information was provided by the initial reporter: back check valve failure ¿ 10012144 primary set.Connected was an icu medical secondary set containing chemo.The secondary bag contents backed up into the primary bag and they said the drip chamber was full.

• Brand Name: BD ALARIS INFUSION 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12801664
• Report Number: 9616066-2021-52412
• Device Sequence Number: 4777936
• Product Code: FPA
• UDI-Device Identifier: 37613203021167
• UDI-Public: 37613203021167
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 10/18/2021

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 Expiration Date: 03/03/2023
• Device Model Number: 10012144
• Device Catalogue Number: 10012144
• Device Lot Number: 20035092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown