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

Catalog Number	21-7036-012
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that this infusion administration set would not prime and the line was full of air.The medication had to be hung and delivered via gravity as the patient had no extra tubing.This increased the medication administration time almost an hour.No adverse patient effects were reported.
Additional Manufacturer Narrative
One cadd administration sets was returned for analysis.The sample was visually inspected at 12" to 24" under normal conditions of illumination.Excess solvent was found inside the union between the inlet filter and the tube 12".Due to the fact there was no lots for p/n 21-7336-01 programed to be manufactured in the near future, per previous complaints a review of the manufacturing process for p/n 21-7394-24 l/n 3730632 was conducted by quality engineer on 07-nov-2018, in order to verify that there are no situations or practices that could create the event as described in "complaint description" section.Production personnel performs 100% visual inspection to verify that the tubing does not display any excessive solvent and wipes the excessive solvent from inside diameter of tube to prevent occlusions or hourglasses.Tubes are not occluded.Tubes are not kinked or coiled too tightly.Tubes shall not have flat spots, or other damage.The most probable root causes are the operator applied an excessive amount of solvent in the bonding in the inlet side of the filter or the production personnel did not detect excess solvent on the 100% visual inspection.To address the possible causes that are within shm's responsibility the following action was taken per previous complaints: cr-10004961 was open on 11-oct-2017 per kaizen event, to implement the replacement of current solvent pots by solvent dispensers.The project is currently in change request review phase.Quality alert qalert-18281 was placed where the production personnel perform the bonding operation on 20-sep-2018, to aware the production personnel are performed correctly the operation.Production personnel was notified by quality engineer on 21-dec-2018 as awareness of the defect reported by the customer.

• Brand Name: CADD® CADD® ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8112485
• Report Number: 3012307300-2018-08515
• Device Sequence Number: 11185761
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 02/28/2020
• Device Catalogue Number: 21-7036-012
• Device Lot Number: 45X084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1