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

Model Number	21-7624-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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 administration set.It was reported that immediately after starting to use the product, the customer found leakage somewhere from the infusion line (the exact leaking spot is not certain).So he stopped using the product; there was no patient injury.
Additional Manufacturer Narrative
One cadd administration set was returned for the evaluation of the reported issue, as well as 3 pictures.A dhr, device history review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.During the analysis conducted it could be observed a top view of the product in the first picture; a focus on the bonding of tube 105 and pump tube showed a leak and a hole under the pump, thus the failure mode reported was confirmed.Upon visual inspection, the sample was received with solvent spill under the pump tube which created a hole, the failure mode reported was confirmed again.The most probable root cause is that the solvent was not properly applied by the operator.

• 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: 11661315
• Report Number: 3012307300-2021-03098
• Device Sequence Number: 16912308
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: 10610586044748
• 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): 06/14/2021

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: 21-7624-24
• Device Catalogue Number: 21-7624-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1