MAUDE Adverse Event Report: ST PAUL 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).Occupation: 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
H3: three pictures of the cadd administration set were reviewed.In two of the pictures, it could be seen that a valve detached from the tube.The third picture showed a tpn product coiled.No testing could be performed because no samples were provided to perform a thorough investigation.The records of pull tests process were reviewed; there were no discrepancies in the results obtained; all averages and individual results for each sample are above 5 lbs, which is the minimum acceptable.The most probable cause of the issue is that the use of dispenser solvent in without stopper originated a lack of solvent.The reported issue was confirmed.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10140870
• Report Number: 3012307300-2020-05805
• Device Sequence Number: 11300785
• 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: 06/21/2020
• Initial Report FDA Received Date: 06/10/2020
• 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: 15 YR
• Patient Weight: 40