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

Model Number 21-7609-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Customer did not provide the lot number of the affected device.

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that immediately after starting to use the product, the customer noticed medical fluid was leaking from the connector.There was no patient injury.

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device, the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed, that this device met all manufacturing specification for product released for distribution.No issues were identified, that would have impacted this event.

• Brand Name: NRFIT
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11381943
• MDR Text Key: 233732442
• Report Number: 3012307300-2021-01578
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: 10610586044014
• Combination Product (y/n): N
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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
• Device Operator: No Information
• Device Model Number: 21-7609-24
• Device Catalogue Number: 21-7609-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1