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

Catalog Number	21-7109-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during use of this smiths medical cadd extension sets, fluid leaked at the filter was noted.It was reported that the patient had to go to the "hospital to receive additional medication with a crisis as per insufficient treatment due to fluid leakage".According to the report, the device was in use with patient for infusion of veletri.No additional adverse effects were reports.
Additional Manufacturer Narrative
One cadd extension sets was returned for analysis.The returned samples consist of one ext.Set products from p/n 21-7109-24 l/n 3607899; and the sample was received in new conditions and with its original unopened packaging.The sample was visually inspected, at a distance of 12" to 24" and normal conditions of illumination and no discrepancies were found.Functional leak testing was performed using hydrostat vessel and no leaks were detected.The customer's reported problem could not be duplicated.No root cause has to be determined since the complaint was not confirmed.No corrective actions required since the complaint was not confirmed, and no fault found.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8453790
• Report Number: 3012307300-2019-01422
• Device Sequence Number: 14200516
• Product Code: FPA
• UDI-Device Identifier: 10610586034497
• UDI-Public: 10610586034497
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K974013
• 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): 08/07/2019

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 Catalogue Number: 21-7109-24
• 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: 02/26/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention