MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR INTRAVASCULAR ADMINISTRATION SET

Model Number MZ5307

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the minibore bi-fuse pressure 2 iv connector experienced component separation. The following information was provided by the initial reporter: a mini bore bi-fuse had the main tubing (before it splits into two smaller lumens) separate from the distal segment where it inserts into the patient.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR
• Type of Device: 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: 12502589
• Report Number: 9616066-2021-52091
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230606
• UDI-Public: 50885403230606
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MZ5307
• Device Catalogue Number: MZ5307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial