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

Model Number 21-7308-24

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

Information was received that while filling up the medication in a smiths medical cadd cassette, the fluid was noted to be leaking.No patient injury occurred.

Manufacturer Narrative

Investigation results completed on a cadd cassette reservoir.Sample was received from p/n 21-7308-24.Unknown lot number, as this device was not in original package.Visually inspected from 12 inches under normal lighting and a leak in the bag was revealed.Testing was done to do pm quality review and duplicate report, which did no verify complaint.The root cause was isolated to ay bag was damage during assembly process, due to a worn tool that had sharp edges, used to removed foreign material and ay bag was mishandled during leak test and not properly segregated.Action taken: co-10074801 was created to update av-0142 rev 100, "doblado de bolsa y ensamble de plato de presion a cassette", to state proper bag assembly care to ensure it is not damage.Complete on 28/feb/2019.

Event Description

Investigation results completed on cadd cassette reservoirs - flow stop.Device analysis in h10.

• Brand Name: SMITHS MEDICAL CADD CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9527519
• MDR Text Key: 177228830
• Report Number: 3012307300-2019-06993
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: 10610586032370
• Combination Product (y/n): N
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

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
• Device Operator: No Information
• Device Model Number: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1