MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 60/10 PCC

Model Number	MMT-884
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 (b)(6).The patient reported that the infusion set's tubing detached between tubing and needle while changing the infusion site.The site location was patient's abdomen and the pump was located at the abdomen as well.Reportedly, the infusions were stored as per the instructions for use.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body no further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 60/10 PCC
• MDR Report Key: 9919506
• Report Number: 3003442380-2020-00235
• Device Sequence Number: 3374749
• Product Code: FPA
• UDI-Device Identifier: 05705244005754
• UDI-Public: 05705244005754
• 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: 02/01/2022
• Device Model Number: MMT-884
• Device Lot Number: 5273230
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1