MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BABY TRIFUSE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	BTF36
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: b3, e2,e3: unknown; no information has been provided to date.Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.For all enquires or follow up questions related to the record, do not use regulatory.Responses@smiths-medical, please direct those to the following: regulatory.Responses@icumed.Com.
Event or Problem Description
User facility reported the device was in use and the luer lock separated from the rest of the infusion set.No adverse effects to patient reported.

• Brand Name: BABY TRIFUSE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 5949999
• Report Number: 2183502-2016-01022
• Device Sequence Number: 18160769
• Product Code: FPA
• UDI-Device Identifier: 10351688511607
• UDI-Public: 10351688511607
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 04/29/2024

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
• Device Catalogue Number: BTF36
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 09/14/2016
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown