MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICROBORE TRI-FUSE EXTENSION SET, 3 IV C; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9273
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.The initial reporter also notified the fda on 2 march, 2021.Medwatch report # (b)(4).Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that microbore tri-fuse extension set, 3 iv c had flow issues.The following information was provided by the initial reporter: material #: mz9273, batch/ lot #: unknown.It was reported that the tubing and filter would not flush.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported that the tubing and filter would not flush.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mz9273 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that microbore tri-fuse extension set, 3 iv c had flow issues.The following information was provided by the initial reporter: material #: mz9273 batch/ lot #: unknown it was reported that the tubing and filter would not flush.

• Brand Name: MICROBORE TRI-FUSE EXTENSION SET, 3 IV C
• 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
• MDR Report Key: 11573040
• Report Number: 9616066-2021-50571
• Device Sequence Number: 19947106
• Product Code: FPA
• UDI-Device Identifier: 10885403240850
• UDI-Public: 10885403240850
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: MZ9273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1