MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-SOLIS AC ADAPTER; PUMP, INFUSION

Catalog Number	21-0270-25
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "ac plug deformation (bending)." it was unknown whether the incident occurred during patient use, but no patient harm or adverse event reported.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection was able to verify the reported problem.The ac plug was determined to be defective.

• Brand Name: CADD-SOLIS AC ADAPTER
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen street; southington CT
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21312976
• Report Number: 3012307300-2025-01508
• Device Sequence Number: 8076218
• Product Code: FRN
• UDI-Device Identifier: 15019517126884
• UDI-Public: (01)15019517126884(17)320202(10)2203
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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: Health Professional
• Device Catalogue Number: 21-0270-25
• Device Lot Number: 2203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0466-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown