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

Model Number	21-7036-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cadd administration set leaked at the filter during priming.There was no reported injury or adverse events.
Additional Manufacturer Narrative
Investigation completed on a smiths medical cadd administration sets - non flow stop.The complaint was verified during testing and by photos provided with leaking at the filter.The product was visualized closely from 12" -16 " and found to have delamination at the join of the tube and adapter tube.When testing was done with hydrostat, leaking was observed between the filter and the coiled tubing.Quality review was done on lots p/n 21-7394-24 l/n 3971624 for lots p/n 21-7036-01 lots were not programmed to be manufactured in the near future.The review on (b)(6) 2020 did not reveal any discrepancies as the tests performed normally.Believed root cause of event was production personal did not detect the bonding malfunction issue prior to release.

• Brand Name: CADD ADMINISTRATION SET- NON FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9895097
• Report Number: 3012307300-2020-02356
• Device Sequence Number: 755028
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: Other
• Device Expiration Date: 09/02/2024
• Device Model Number: 21-7036-01
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 3873550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/29/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1