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

Catalog Number 21-7394-24

Device Problem Decoupling (1145)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2018

Event Type  malfunction  

Event Description

Information was received that the cadd administration set had a connection that fell off.No reported adverse effects.

Manufacturer Narrative

The cadd administration set was returned for analysis and the sample was visually inspected under normal conditions of illumination.The sample was received with the asv valve placed on the tube and was easily removed.A review of the manufacturing process was conducted in order to verify that there are no situations or practices that could create the reported event.The most probable cause is that the operator did not applied solvent in the bonding between the asv valve and the tube.Another factor is that the solvent pots do not show a solvent level.A current process is being implemented to replace the current solvent pots by solvent dispensers.Training is being provided to production personnel in order to reinforce the bonding verification process.Production personnel are also being made aware that they should perform a verification of the container levels and it shows them the differences between a tube with solvent and one without it.

• Brand Name: CADD ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8201293
• MDR Text Key: 131587914
• Report Number: 3012307300-2018-09020
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 3675226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1