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

Catalog Number 21-7361-24

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2023

Event Type  malfunction  

Event Description

It was reported the disposable had multiple kinks and some liquid leaks.It is unknown if there was patient involvement and no adverse patient effects were reported by the customer.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: d3, g1,2 email is: regulatory.Responses@icumed.Com one device was returned for evaluation.Visual inspection revealed no obstructions, damaged, broken, or other defects.Functional testing could not replicate the reported issue; no leaks were identified.The root cause could not be determined.No further action was taken.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• 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: 17410470
• MDR Text Key: 320023162
• Report Number: 3012307300-2023-07547
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191738
• UDI-Public: 15019517191738
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7361-24
• Device Lot Number: 4268012
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1