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

Model Number	0.2 FLTR, COILED TUBE,BLUE STRIPE15/BX
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two pictures of a cadd administration sets were received.The pictures were analysis, and the label and the ifu of the rra product; however, no leaks are visible in any of them.No testing could be performed because no samples were provided to perform a thorough investigation.No root cause has to be determined since the reported failure mode was not confirmed due to the fact that no samples were received to perform a thorough investigation.According to the investigation, no actions are required since the complaint was not confirmed.However, manufacturing personnel was notified by the area quality engineer as awareness of the failure mode reported by the customer.
Event or Problem Description
Information was received that during using of this smiths medical cadd administration sets, leaking was noticed from the set air filter at the top left corner on the green backing side.It was reported that the patient was connected to the infusion and it was started, and it was noted that there was a small wet spot on the client's bedding.According to the report, upon inspection of the tubing it was noted that the air filter was leaking at the top left corner on the green backing side.No reported adverse effects or patient injury.

• Brand Name: CADD ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10134804
• Report Number: 3012307300-2020-04703
• Device Sequence Number: 16907495
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: No Information
• Device Expiration Date: 08/14/2024
• Device Model Number: 0.2 FLTR, COILED TUBE,BLUE STRIPE15/BX
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 3855114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Initial 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