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

Model Number	21-7608-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer did not provide the lot number of the affected device.
Event or Problem Description
Information was received regarding a cadd extension set.It was reported that immediately after starting to use the product, the customer noticed medical fluid was leaking from the medication cassette.There was no patient injuries noted.
Additional Manufacturer Narrative
Other, other text: a photo of the device was received for evaluation.During the evaluation 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
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11373540
• Report Number: 3012307300-2021-01503
• Device Sequence Number: 14398216
• Product Code: LHI
• UDI-Device Identifier: 10610586043994
• UDI-Public: 10610586043994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2021

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
• Operator of Device: No Information
• Device Model Number: 21-7608-24
• Device Catalogue Number: 21-7608-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1