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

Model Number 21-7609-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that during the use of a smiths medical cadd cassette reservoir and a smith medical cadd extension set, it was noticed that medical fluid was leaking from the connection part.There was no patient injury.

Manufacturer Narrative

Other, other text: h3: one picture of a cadd cassette reservoir was received and reviewed.The picture showed a yellow connector and no discrepancies were found.One cadd cassette reservoir from part number 21-7600-24 and unknown lot number was received in used condition without its original packaging inside a plastic bag filled with water.The cassette was visually inspected, at a distance of 12" to 24" and normal conditions of illumination.No discrepancies were detected.A syringe was used to infuse water into the assembly (ay) bag and no leaks were detected.The reported leak was unable to be confirmed since there was no fault found with the returned cassette.

• Brand Name: CADD CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10374052
• MDR Text Key: 201888140
• Report Number: 3012307300-2020-07890
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: 10610586044014
• Combination Product (y/n): N
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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: 21-7609-24
• Device Catalogue Number: 21-7609-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1