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

Model Number	21-7381-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Fragmentation (1261)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Regional nurse manager.
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set tubing got detached during the administration of total parenteral nutrition (tpn).The end of the administration set fell off.There was no reported adverse event.
Additional Manufacturer Narrative
Device evaluation: three pictures of cadd administration sets were received by shm for analysis, and in two of them it valve detached from the tube was observed and the third picture showed a tpn product coiled.No testing could be performed because no samples were provided to perform a thorough investigation.The customer's reported problem was confirmed.According to the investigation, the most probable root cause is that the use of dispenser solvent in without stopper originated a lack of solvent.According to the investigation production personnel was trained in order to reinforce the solvent application.The problem source of the reported problem is manufacturing.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10142958
• Report Number: 3012307300-2020-03967
• Device Sequence Number: 2630178
• Product Code: FPA
• UDI-Device Identifier: 10610586027468
• UDI-Public: 10610586027468
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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 Expiration Date: 02/15/2025
• Device Model Number: 21-7381-24
• Device Catalogue Number: 21-7381-24
• Device Lot Number: 3935900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 35