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

Catalog Number	21-2188-25
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that immediately on use, the smiths medical cadd accessory kept on breaking and ultimately falling out.The reporter indicated that replacement of the locks did not solve the issue, and that the lock boxes were faulty.The reporter also indicated that the patient had removed the medication and staff caught them.No patient consequences were reported, and no adverse effects were reported.

• Brand Name: CADD ACCESSORIES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8570646
• Report Number: 3012307300-2019-02296
• Device Sequence Number: 16528417
• Product Code: FPA
• UDI-Device Identifier: 10610586035029
• UDI-Public: 10610586035029
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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 Catalogue Number: 21-2188-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1