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

Catalog Number 21-7394-24

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

One cadd administration set was returned for investigation.The samples were visually inspected at a distance of 12 to 24 inches under normal conditions of illumination.The samples were visually inspected and no abnormalities were observed.Functional testing was performed to look for unusual functions.The tests found no indication of a loose connection.The dimensions of the components were within specification.A root cause could be established since the complaint was not confirmed.

Event Description

Information was received indicating that a smiths cadd extension set becomes disconnected from the device.It was also reported that the extension set was difficult to prime.No patient injury or complications were reported in relation to this event.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9194216
• MDR Text Key: 169086698
• Report Number: 3012307300-2019-05514
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7394-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1