MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-IN STD BORE BI-FURCATED EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1247
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed because a valid lot number was not provided by the customer.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: no product will be returned per customer.No investigation was performed.
Event or Problem Description
It was reported that the 7-in std bore bi-furcated ext set experienced leakage.The following information was provided by the initial reporter: material no: me1247, batch no: unknown.Product leaking at y- site connection while infusing cytotoxic medication.Replacing splitter resolved the problem.

• Brand Name: 7-IN STD BORE BI-FURCATED EXT 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: 11068734
• Report Number: 9616066-2020-20644
• Device Sequence Number: 19576847
• Product Code: FPA
• UDI-Device Identifier: 10885403274305
• UDI-Public: 10885403274305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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 Catalogue Number: ME1247
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1