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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
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 the 60 in ultra minibore extension set tubing leaked.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "tubing and/or connection site leaking ( a few drops).Tubing changed and saved to give to supervisor.(biomed was unable to duplicate leak with given tubing)".
Additional Manufacturer Narrative
Investigation summary customer reported the tubing was leaking at a connection site, and returned the affected sample.The sample was primed with a syringe full of blue dye water, and no leak was found.The complaint was unable to be verified and no failure mode was seen.This is not a failure mode as there was flow, but it should be noted the line was abnormally hard to flow through, and seemed occluded in some way.A device history record review could not be performed on model me2017, because a lot number was not provided by the customer.H3 other text : see h.10.
Event or Problem Description
It was reported that the 60 in ultra minibore extension set tubing leaked.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "tubing and/or connection site leaking ( a few drops).Tubing changed and saved to give to supervisor.(biomed was unable to duplicate leak with given tubing)".

• 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: 10891341
• Report Number: 9616066-2020-20409
• Device Sequence Number: 16950913
• 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,Followup
• Report Date (Section B): 12/09/2020

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
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1