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

Model Number 21-7345-24

Device Problem Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

It was reported that the patient was receiving epoch.It was reported that the drug didn't infuse from (b)(6) 2022 to (b)(6) 2022.No patient injury was reported.

Manufacturer Narrative

Other, other text: 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.Lot/serial number not provided.

Manufacturer Narrative

H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.No lot number was provided; therefore, device history review could not be performed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 10; minneapolis, MN 55442
• MDR Report Key: 15233829
• MDR Text Key: 297977314
• Report Number: 3012307300-2022-15413
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191714
• UDI-Public: 15019517191714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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: Lay User/Patient
• Device Model Number: 21-7345-24
• Device Catalogue Number: 21-7345-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/28/2022
• 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
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic