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

Catalog Number	21-7001-24
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
Ten cadd cassette reservoir were returned for analysis.The sample was visually inspected, at a distance of 12" to 24" and normal conditions of illumination.Using a syringe it was tried to pass water through the sample in order to confirm the leakage.The ten (10) samples presented a leakage located in the top edge of the corner.The bag loading operation in the cassette line was reviewed; no discrepancies were found.The segregation practice where the burst test takes place in the magnus production line was reviewed; no discrepancies were found.The leak test was audited during ten (10) cycles, in order to verify that the leak test was properly performed; for each cycle five (5) units are tested.The leak test was performed according to the test method stated in the manufacturing procedure; no leakages were detected during the fifty (50) units tested.The most probable root cause is during assembly process in the bag loading operation the bag was not handled property.

• 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
• MDR Report Key: 8497148
• Report Number: 3012307300-2019-01496
• Device Sequence Number: 1650778
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: No Information
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 21-7001-24
• Device Lot Number: 3666981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1