MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7609-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: d4: expiration date, and lot number are unknown; h4: unknown investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the disposable exhibited a leak while in use.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.One device was returned for evaluation.Visual inspection revealed no damages, bad bonds, cuts or kinks detected.Functional testing was performed and a leak was detected in the connector part.Also, a gap in the insertion was identified during tube insertion verification.The root cause of the reported issue is currently under investigation.Actions will be determined and implemented based on the investigation.No lot number was provided; therefore, a history record review could not be conducted.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17958228
• MDR Text Key: 325957994
• Report Number: 3012307300-2023-09723
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: 10610586044014
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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: Health Professional
• Device Catalogue Number: 21-7609-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1