MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 60/8 PCC

Lot Number	5220766
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported tubing detachment and stated that while she was changing her set, she put it on her body and the end popped out.The infusion set disconnected and the piece that was in her body popped off at the site.Patient's weight was (b)(6).Upon investigation, it was found that the tubing was detached from the tubing connector due to missing glue.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 60/8 PCC
• MDR Report Key: 8469611
• Report Number: 3003442380-2019-00589
• Device Sequence Number: 19190469
• Product Code: FPA
• UDI-Device Identifier: 05705244005792
• UDI-Public: 05705244005792
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: No Information
• Device Expiration Date: 12/01/2021
• Device Lot Number: 5220766
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1