MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICRO EXT SET W/1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010983
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint it was reported that there was an occlusion within the tubing sets could not be verified due to the product not being returned for failure investigation.A device history record review for model 10010983 lot number 20055744 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29may2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Rationale: per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
Event or Problem Description
It was reported that micro ext set w/1 ss vlv tubing was occluded.The following information was provided by the initial reporter: material no.: 10010983.Lot no.: 20055744.It was reported that there was an occlusion within the tubing sets.

• Brand Name: MICRO EXT SET W/1 SS VLV
• 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: 10694545
• Report Number: 9616066-2020-20087
• Device Sequence Number: 3486364
• Product Code: FPA
• UDI-Device Identifier: 50885403233577
• UDI-Public: 50885403233577
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 10/06/2020

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: 05/29/2023
• Device Model Number: 10010983
• Device Catalogue Number: 10010983
• Device Lot Number: 20055744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other