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

Model Number	21-7115-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the device had a leak.No patient injury was reported.
Additional Manufacturer Narrative
D3: report source: updated h6: health impact and evaluation codes: updated a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: CADD EXTENSION SETS
• Common Device Name: 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; minneapolis, MN 55442
• MDR Report Key: 15239917
• Report Number: 3012307300-2022-15480
• Device Sequence Number: 6314982
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: 10610586034503
• Combination Product (Y/N): N
• Initial Reporter Country: FP
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2026
• Device Model Number: 21-7115-24
• Device Catalogue Number: 21-7115-24
• Device Lot Number: 4192045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown