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

Model Number 21-7230-24

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Event Description

Information was received that upon removal of a smiths medical cadd cleo infusion set, cathalon did not come out and stayed under the skin.The clysis had only been in for three days before being changed.No patient injury resulted.

Manufacturer Narrative

One cadd cleo infusion sets was returned for analysis.The returned sample was received for evaluation from p/n 21-7230-24; the sample was received in used condition without its original package.The sample was visually inspected, at a distance of 12" to 24" and normal conditions of illumination and the cannula was found broken.According to the investigation, functional testing was performed by using three samples of p/n 21-7230-24 l/n 3965585 taken from cleo production line and tested and after removing the white cap the site was inserted into the insertion pad.The inserted cannula was twisted around and pulled from the insertion pad, in neither of the worse test cases produced can cause the cannula to brake or detach and no detachment was detected in any of the tested samples and the cannula was not remove from the site.However, the customer reported problem "the cannula did not come out and stayed under the skin" was confirmed.According to the investigation, in order to perform a complete root cause analysis of this failure mode further investigation was implemented.The problem source of the reported problem is manufacturing.

• Brand Name: SMITHS MEDICAL CADD CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 9918096
• MDR Text Key: 186281961
• Report Number: 3012307300-2020-02581
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• Combination Product (y/n): N
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

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: No Information
• Device Model Number: 21-7230-24
• Device Catalogue Number: 21-7230-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1