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
Foreign 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: this mdr was generated under protocol b10009704, as a result of warning letter (b)(4).Additional information is provided in h3, h6, and h10.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Ten (10) samples were received and visually inspected under normal conditions of illumination finding no issues.Functional testing was performed by using a syringe to infuse water into the bag finding a leakage was detected in one of the top corners of the bag.The root cause of the reported failure was deemed to be manufacturing-related; it was most likely that during assembly process in the bag loading operation, the ay bag was not handled property.Action(s) taken to mitigate the reported issue(s): training to production and quality personnel on proper bag assembly care by training personnel.

• 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: 8499854
• Report Number: 3012307300-2019-01916
• Device Sequence Number: 14157340
• 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
• 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: 10/21/2022
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 10/29/2022
• 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