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

Model Number	21-7107-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical cadd extension set was leaking from the "anterior portion of the filter located on the extension tubing." it was reported that the issue was noticed after a labor epidural was administered and the epidural infusion was started.No adverse patient effects were reported.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd extension set was returned for analysis in a used condition.The sample was visually inspected under normal conditions of illumination and no discrepancies were found.Functional test: leak test was performed using hydrostat vessel and no leaks were detected.Based on the evidence, the complaint was not confirmed, and no fault was found.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8716694
• Report Number: 3012307300-2019-03174
• Device Sequence Number: 2091389
• Product Code: FPA
• UDI-Device Identifier: 10610586029714
• UDI-Public: 10610586029714
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: 21-7107-24
• Device Catalogue Number: 21-7107-24
• Device Lot Number: 3736066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 87