MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFITV; ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS

Model Number	21-7624-24
Medical Device Problem Codes	Failure to Prime (1492); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that during the pre-use check medical fluid would not pass through the device while attempting to prime.No patient injury was reported.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-12532.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFITV
• Common Device Name: ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14806771
• Report Number: 3012307300-2022-12532
• Device Sequence Number: 14686246
• Product Code: PWH
• UDI-Device Identifier: 10610586044748
• UDI-Public: 10610586044748
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 01/03/2024
• Device Model Number: 21-7624-24
• Device Catalogue Number: 21-7624-24
• Device Lot Number: 4230898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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