MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICROBORE BI-FUSE EXTENSION SET, 2 IV CO; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9265
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one sample was received for quality investigation.The customers complaint of component damage was not verified by visual inspection.Inspection of the sample indicates that one of the microbore connectors separated from the assembly.The microbore connector was not returned with the assembly and therefore damage to the connection could not be verified.A device history record review could not be performed on model mz9265 because a lot number was not provided by the customer.The root cause for the separation is a lack of solvent on the tubing causing the tubing to separate from the luer connection.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.The root cause for the separation is a lack of solvent on the tubing causing the tubing to separate from the luer connection.
Event or Problem Description
It was reported that the microbore bi-fuse extension set, 2 iv co experienced component separation.The following information was provided by the initial reporter: material #: mz9265 batch/lot # unknown.Recently i have had two nurses bring me two different products that were in use on patients failed.One is the tri-fuse connector, one of the ends came off (broken below luer).The other is the 0.2 micron filter set, low sorb, which was leaking at the filter.

• Brand Name: MICROBORE BI-FUSE EXTENSION SET, 2 IV CO
• 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: 11168345
• Report Number: 9616066-2021-50042
• Device Sequence Number: 3581490
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: 10885403240775
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 01/11/2021

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: MZ9265
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1