MAUDE Adverse Event Report: ST PAUL CADD CLEO INFUSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Disorders (4543)

Event Type  malfunction  

Event Description

It was reported during a survey that during patient use of the device, the patient developed lipodystrophy around the site of the injection.No other information is known.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No investigation or root cause analysis could be conducted given that no complaint sample was returned.D4: udi information and catalog number were unknown.E4: unknown.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16742537
• MDR Text Key: 313309152
• Report Number: 3012307300-2023-04128
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1