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

Model Number	MZ9265
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that microbore bi-fuse extension set, 2 iv co had foreign matter on 12 occasions.The following information was provided by the initial reporter: customer asks if the yellow coloration in maxzero connector is normal, informed that the material in okay with expiration date.The sales rep that identified the color, there was no patient involvement and its usage is only as selling sample.
Additional Manufacturer Narrative
H.6.Investigation: a mz9265 sample was not required for investigation of this feedback as the customer provided photographs of the affected sample.Analysis of the photographs confirmed the customer's experience with the tubing noted to be discoloured yellow.A review of the production records as well as the sterilization records for lot 17118173 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Yellow discolouration of the tubing can typically occur after irradiation sterilisation and the degree of discolouration can change over time and under certain storage conditions.This type of discolouration does not however affect the functionality of the device and therefore is considered to be a cosmetic defect.
Event or Problem Description
It was reported that microbore bi-fuse extension set, 2 iv co had foreign matter on 12 occasions.The following information was provided by the initial reporter: customer asks if the yellow coloration in maxzero connector is normal, informed that the material in okay with expiration date.The sales rep that identified the color, there was no patient involvement and its usage is only as selling sample.

• 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: 10703513
• Report Number: 9616066-2020-20111
• Device Sequence Number: 4135199
• Product Code: FPA
• UDI-Device Identifier: 50885403240773
• UDI-Public: 50885403240773
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K140831
• 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,Followup
• 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 Expiration Date: 11/24/2020
• Device Model Number: MZ9265
• Device Catalogue Number: MZ9265
• Device Lot Number: 17118173
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1