MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT CONNECTOR ADAPTER LUER; SET, I.V. FLUID TRANSFER

Catalog Number	21-7664-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the adapter of the cadd cassette was leaking at the connection on the middle.There was no patient involvement, and no harm reported.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: one component was returned for investigation.The component was air leak tested per icu medical specifications and failed.The complaint can be confirmed.A quality alert has been posted covering proper solvent application for associate review.In the past two years, no other complaints have been filed for the described defect.Icu medical continues to track and trend complaints data and escalate as needed.No non-conformance reports were issued against this lot during the manufacturing.

• Brand Name: NRFIT CONNECTOR ADAPTER LUER
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20175801
• Report Number: 1526863-2024-00084
• Device Sequence Number: 8196498
• Product Code: LHI
• UDI-Device Identifier: 10610586044021
• UDI-Public: (01)10610586044021(17)270430(10)6010324
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 21-7664-24
• Device Lot Number: 6010324
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2014
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown