MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SET, ADMIN, CADD, 114", SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7333-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set was found to be leaking in two separate lines.The leakage was visible and localized to right below of the cassette and nutrition solution was spraying out from the tube.The infant was being treated by home hospital at home and they discontinued using tubings from the same lot.There were no reported adverse events.
Additional Manufacturer Narrative
Cadd administration sets returned for analysis.The sample consist of thirty (30) product from p/n 21-7333-24 l/n 3761259 and the returned samples were received in unused conditions inside they original sealed shelf boxes.The samples were visually inspected at a distance of 12" to 16" under normal conditions of illumination.According to the investigation, the bonding between the tubing 12" and pump tube does not present enough solvent in most of the samples received, and cavity can be seen in this bonding; however, no discrepancies were detected on filters.Leak testing on the samples received were performed using hydrostat vessel to look for unusual functions and from the 30 samples received, only 15 samples were tested due to the confirmation of both reported failure mode.The customer's reported problem was confirmed.According to the investigation, most probable root cause for failure mode leaking from filter is the filter became damage after the product left shm facilities, or the filter was received damaged from the supplier.Preventive action quality alert was placed, where production personnel perform leak testing, in order to increase temporarily the frequency of inspection performed by operators to models with the filter at 200% for hydrostatic testing.According to the investigation, the problem source of the reported problem is manufacturing.

• Brand Name: SET, ADMIN, CADD, 114", SPIKE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9168047
• Report Number: 3012307300-2019-05237
• Device Sequence Number: 14363208
• Product Code: FPA
• UDI-Device Identifier: 10610586043239
• UDI-Public: 10610586043239
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K040636
• 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): 01/13/2020

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: No Information
• Device Expiration Date: 02/16/2024
• Device Model Number: 21-7333-24
• Device Lot Number: 3761259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/14/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1