MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; INFUSION PUMP

Model Number	21-7386-24
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received regarding a cadd administration set.It was reported that device broke in the middle of the night during infusion.The medication did not leak on the patient.The sample was discarded.There was no injury noted.

• Brand Name: CADD
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11548208
• Report Number: 3012307300-2021-02393
• Device Sequence Number: 19816433
• Product Code: FPA
• UDI-Device Identifier: 15019517161977
• UDI-Public: 15019517161977
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031361
• 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): 02/24/2022

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: Lay User/Patient
• Device Expiration Date: 02/05/2025
• Device Model Number: 21-7386-24
• Device Catalogue Number: 21-7386-24
• Device Lot Number: 3935910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown