MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; 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	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set leaked a significant amount of blood and the peripherally inserted central catheter (picc) line was broken in two, cracking the air filter.The reporter indicated that per the client, the cause of the damage in this event was unknown.No further adverse effects were reported.No patient consequences were reported.
Additional Manufacturer Narrative
One cadd administration sets - non flow stop was returned for analysis due to leakage.The sample was visually inspected at a distance of 12? to 16? under normal conditions of illumination.The sample was received broke from filter, the coiled tube came with a filter port inside it.The manufacturing process was reviewed.Production personnel perform a pull test on 4 units, at shift start up, the beginning of every job, the end of every job; a new lot of materials/components or equipment adjusted.During the manufacturing process, production personnel do a visual inspection before a process (assemble, bond, etc.) to ensure that the material is in perfect shape; also right after a work station, personnel redo an inspection to the filter in order to find any discrepancies, following the following criteria.Holes in filter membrane.-incomplete or poor filter assembly.Quality personnel take a sample of 15 units every 2 hours, prior to placing product in bag in order to inspect the filter for proper housing welds or other workmanship defects.Parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts, or other workmanship defects that can affect assembly function or appearance.The most probable root cause is that the filter was damaged after the product left the facility.Device history review: part number: 21-7036-01 lot number: 3840952 manufacturing date: july, 2019 quantity released: (b)(4) any relevant dmrs, idrs, das: there were no relevant idr's, dmr's or da's for this lot.Any relevant rework: none per review of the dhr's.Was scrap/rejects above typical? none per review of the dhr's.Component lot number and quantity issued: there is no component associated with this complaint.Component history: there is no component associated with this complaint.Summary of dhr review: there were no relevant findings detected in the dhr's.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9633799
• Report Number: 3012307300-2020-00727
• Device Sequence Number: 2800372
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/16/2024
• Device Model Number: 21-7036-01
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 3840952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1