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

Catalog Number	21-7061-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that after five hours of use of the smiths medical cadd extension set, it was noted that the connection point was leaking.No adverse effects were reported.
Additional Manufacturer Narrative
The device was no returned but conclusions were able to be drawn from a picture that was received.In the picture, it was observed that there was an arrow showing a small point in the male luer.No leaks can be confirmed or observed since the device was not returned.A review of the manufacturing process was conducted in order to verify that there are no situations or practices that could create the event as described in "description of non-conformance" section.All procedures are being carried appropriate.Quality personnel takes 15 sample units every two (2) hours to inspect: parts are free of excessive bonding residue and smudges, tubes are not occluded, tubes are not kinked or coiled too tightly, parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts or other workmanship defects that can affect assembly function or appearance.

• 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: 8912833
• Report Number: 3012307300-2019-04238
• Device Sequence Number: 13910605
• Product Code: FPA
• UDI-Device Identifier: 10610586020445
• UDI-Public: 10610586020445
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: No Information
• Device Expiration Date: 03/29/2023
• Device Catalogue Number: 21-7061-24
• Device Lot Number: 3607921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1