MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW PROTECTION; PUMP, INFUSION

Catalog Number	21-0346-25
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a large volume extension set was leaking, despite having the clamp on.No patient injury resulted.This incident was for training purposes.

• Brand Name: CADD® ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW PROTECTION
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7773979
• Report Number: 3012307300-2018-03092
• Device Sequence Number: 13732777
• Product Code: FRN
• UDI-Device Identifier: 00610586100478
• UDI-Public: 00610586100478
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K894360
• 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
• Report Date (Section B): 08/10/2018

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: No Information
• Device Catalogue Number: 21-0346-25
• Device Lot Number: 17082201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1