MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 60 IN ULTRA MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME2017
Medical Device Problem Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: one sample of model me2017 was received for quality investigation.The customer complaint that the tubing had cracked which resulted in the tube leaking and blood backing up in the line, was verified by visual inspection.Visual inspection indicated a crack from the female luer lock thread with a significant amount of the luer lock thread missing.No further defects were observed.A device history record review could not be performed on model me2017 because a lot number was not provided by the customer.Although the root cause cannot be definitively determined, excessive tightening the luer connection can cause the cracks seen in the female luer.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: one sample of model me2017 was received for quality investigation.The customer complaint that the tubing had cracked which resulted in the tube leaking and blood backing up in the line, was verified by visual inspection.Visual inspection indicated a crack from the female luer lock thread with a significant amount of the luer lock thread missing.No further defects were observed.Although the root cause cannot be definitively determined, excessive tightening the luer connection can cause the cracks seen in the female luer.
Event or Problem Description
It was reported that the 60 in ultra minibore extension set experienced cracks -microchannel issues and blood backflow during infusion.The following information was provided by the initial reporter: material #: me2017, batch/ lot #: unknown.Rn changed out pt dexmed drip.Upon doing her safety checks, rn noticed pt's drip line was backing up with blood and there was fluid on the floor.Upon further inspection, rn noted that the tubing where the dexmed was running had cracked at the end and was running onto the floor,.

• Brand Name: 60 IN ULTRA MINIBORE EXTENSION 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: 10891471
• Report Number: 9616066-2020-20411
• Device Sequence Number: 3228335
• Product Code: FPA
• UDI-Device Identifier: 50885403236240
• UDI-Public: 50885403236240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 11/09/2020

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 Model Number: ME2017
• Device Catalogue Number: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1