MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Inflammation (1932); Device Embedded In Tissue or Plaque (3165)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Other, other text: four cadd cleo infusion sets were returned for analysis.The samples were visually inspected, at a distance of 12? to 24? and normal conditions of illumination.The cannula was found to be broken in one of the samples.A review of the manufacturing process was conducted and all the procedures were found to be followed properly.Functional tests were also performed.Three samples were taken from the cleo production line and tested; after removing the white cap the site was inserted into the insertion pad.No detachment was detected in any of the tested samples and the cannula was not removed from the site.The retractor assemblies are 100% visually inspected by the production personnel to assure that the needle is properly threaded.Quality control performs an in-process audit at 1-hour intervals to verify that needle is properly threaded on the retractor assemblies.Device history review: part number =21-7230-24.Lot number=78x094.Quantity released =8,100 units.Manufacturing date =january 2018.Idr, dmr, or da=none per review of the dhr.Part number =21-7230-24.Lot number =76x099.Quantity released =8,100 units.Manufacturing date =june 2016.Idr, dmr, or da=none per review of the dhr.Part number =21-7230-24.Lot number =77x094.Quantity released =8,100 units.Manufacturing date =july 2017.Idr, dmr, or da=none per review of the dhr.Part number =21-7230-24.Lot number =77x143.Quantity released =8,100 units.Manufacturing date =september 2017.Idr, dmr, or da=none per review of the dhr.

Event Description

Information was received indicating that the cannula remained in the patient's body after using the cadd cleo infusion set.The patient underwent a ct scan that showed the presence of ?lines".The patient was reported to have three ?raised bumps" and was told the cannula will probably eventually come out naturally.

• Brand Name: CADD
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10126646
• MDR Text Key: 194300832
• Report Number: 3012307300-2020-05569
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 06/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1