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

Catalog Number	21-7045-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that this extension set exhibited leakage.It was noted that the tubing had not come apart and the medication was leaking at the connection.The medicaion was all over the pump and bag.The patient was not hooked up and there was no patient involved.

• Brand Name: CADD® CADD® EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7736624
• Report Number: 3012307300-2018-02884
• Device Sequence Number: 1018868
• Product Code: FPA
• UDI-Device Identifier: 30610586020296
• UDI-Public: 30610586020296
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 02/09/2022
• Device Catalogue Number: 21-7045-24
• Device Lot Number: 57X053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1