MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MBF27 SMITHS MEDICAL MINI BIFUSE 2 TO 1 ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MBF27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical medex administration set had a crack in the hub connection.Patient was noted to have acquired an infection.As a result, a complete sterile line change was done immediately.

• Brand Name: MBF27 SMITHS MEDICAL MINI BIFUSE 2 TO 1 ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8323505
• Report Number: 3012307300-2019-00648
• Device Sequence Number: 16519171
• Product Code: FPA
• UDI-Device Identifier: 10351688510471
• UDI-Public: 10351688510471
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K841882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 08/06/2021
• Device Catalogue Number: MBF27
• Device Lot Number: 3671270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention