MAUDE Adverse Event Report: NULL CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Biocompatibility (2886)

Patient Problem Local Reaction (2035)

Event Type  malfunction  

Manufacturer Narrative

No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review could not be performed as the catalog number and lot number were unknown.No root cause could be determined as the complaint could not be confirmed.Study response id (b)(4) this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during in home use of the device, there was one event of allergic reaction.Additional information indicated patient allergic to wasps.No patient injury was reported.

• Brand Name: CADD CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 15362603
• MDR Text Key: 305596687
• Report Number: 3012307300-2022-17942
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2022

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 09/06/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1