MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD HIGH VOLUME ADMINISTRATION SETS WITH FLOW STO; SET, I.V. FLUID TRANSFER

Model Number	21-7665-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the filter was leaking.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found no damages or other defects were detected.Functional testing found the leak on the filter was detected; thus, the failure mode reported confirmed.No root cause could be related to manufacturing process was determined.An internal scar has been issued to supplier on 06-jul-2021, in order to perform a complete root cause analysis for the failure mode reported for leak in filters due previous complaints for this failure.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: h4: device manufacturing date and d4: device expiration date.

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SETS WITH FLOW STO
• Common Device Name: SET, I.V. FLUID TRANSFER
• 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: 14620504
• Report Number: 3012307300-2022-10920
• Device Sequence Number: 4574706
• Product Code: LHI
• UDI-Device Identifier: 15019517184259
• UDI-Public: 15019517184259
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162219
• 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): 04/21/2023

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: 11/23/2022
• Device Model Number: 21-7665-24
• Device Catalogue Number: 21-7665-24
• Device Lot Number: 4080943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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