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

Catalog Number	21-2188-25
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the cadd solis lockbox was able to be opened without a key by pushing on the side of the box.No reported adverse effects.
Additional Manufacturer Narrative
One cadd-solis lock box was returned for analysis.Simulated use and visual inspection was the method used to conduct the investigation.Visual inspection found the locking mechanism on the lock box intact without missing pieces or parts.One of the retention pins inside the box was slightly bent.Simulated use was able to lock the box and unable to replicate the reported issue of opening the lock box by pushing on lower right corner of the lockbox.As per cadd-solis lock box instructions for use the lock box is not designed to prevent theft.

• Brand Name: CADD LOCKBOX
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7964890
• Report Number: 3012307300-2018-00782
• Device Sequence Number: 11150989
• Product Code: FRN
• UDI-Device Identifier: 10610586035029
• UDI-Public: 10610586035029
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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 Expiration Date: 01/18/2021
• Device Catalogue Number: 21-2188-25
• Device Lot Number: W930920/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1