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

Model Number	21-7333-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received indicating that the bag within this cadd cassette was leaking.The reported event was noticed while filling the cassette.There was no patient involved during the reported event.
Additional Manufacturer Narrative
Other, other text: additional information provided h3, h6 and h10.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was performed and there were no relevant findings.The device was returned for analysis and has been evaluated.The returned device consisted of ten samples which were received in used condition without its original packaging.Visual and functional testing were performed.The ten samples were visually inspected individually at a distance of 12 inches to 24 inches and normal conditions of illumination.During visual inspection, no discrepancies were detected.During functional test, a syringe was used to infuse water into the ay bag.The ten samples presented leakage located in the top edge of the corner.The root cause of the reported event was due to manufacturing.During the assembly process, the ay bag was not handled properly during loading operation.Actions were taken to mitigate the reported issue: no actions were taken for the primary concern reported; however, training to production and quality personnel will be required.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• 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: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8499855
• Report Number: 3012307300-2019-01919
• Device Sequence Number: 14122077
• Product Code: FPA
• UDI-Device Identifier: 10610586043239
• UDI-Public: 10610586043239
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: 21-7333-24
• Device Catalogue Number: 21-7001-24
• Device Lot Number: UNKNOWN
• 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: 03/12/2019
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 10/28/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown