MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD CASSETTE RESERVOIRS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7390-24
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the registered nurse found the patient's epidural tubing disconnected at the connection site.The site was approximately disconnected for an hour.There was no reported injury to the patient.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8806927
• Report Number: 3012307300-2019-02929
• Device Sequence Number: 18912097
• Product Code: FPA
• UDI-Device Identifier: 10610586027505
• UDI-Public: 10610586027505
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: Health Professional
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: 21-7390-24
• Device Lot Number: 45X477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR