MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. Y MICROBORE EXT W/LUER & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	10794983
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on 13 october, 2020.Medwatch report # (b)(4).Report source other: medwatch report.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint that bifuse cracked causing smof lipids to not infuse for an unknown amount of time could not be verified due to the product not being returned for failure investigation.A device history record review for model 10794983 lot number 20036895 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25mar2020.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.
Event or Problem Description
It was reported that y microbore ext w/luer & 2 sld clp was cracked and caused underinfusion.The following information was provided by the initial reporter: material no: 10794983 batch no: 20036895.It was reported that bifuse cracked causing smof lipids to not infuse for an unknown amount of time.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint that bifuse cracked causing smof lipids to not infuse for an unknown amount of time could not be verified due to the product not being returned for failure investigation.A device history record review for model 10794983 lot number 20036895 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of component damage with leakage with lot #20036895 regarding item #10794983.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that y microbore ext w/luer & 2 sld clp was cracked and caused underinfusion.The following information was provided by the initial reporter: material no: 10794983; batch no: 20036895.It was reported that bifuse cracked causing smof lipids to not infuse for an unknown amount of time.

• Brand Name: Y MICROBORE EXT W/LUER & 2 SLD CLP
• 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: 10795447
• Report Number: 9616066-2020-20264
• Device Sequence Number: 16761628
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: 50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 03/25/2023
• Device Model Number: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: 20036895
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1