MAUDE Adverse Event Report: ST PAUL CLEO 90 SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Local Reaction (2035)

Event Type  malfunction  

Manufacturer Narrative

Other text: his remediation mdr was generated under protocol b10010116, as a result of warning letter (b)(4).The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.D4 is unknown.

Event Description

It was reported in an anonymous survey that the patient experienced pruritus.No medical or surgical intervention was reported.

• Brand Name: CLEO 90 SUBCUTANEOUS INFUSION SET
• 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: 16883397
• MDR Text Key: 314720922
• Report Number: 3012307300-2023-05276
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2023
• 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: 04/28/2023
• 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