MAUDE Adverse Event Report: SURE-T PARADIGM; CONTACT DETACH G29 46/6 PCC

Model Number	MMT-862
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the infusion set's tubing detached at the quick release.The patient noticed the insulin out of the tubing after changing the set.This issue occurred with two infusion sets.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: CONTACT DETACH G29 46/6 PCC
• MDR Report Key: 10565213
• Report Number: 3003442380-2020-00385
• Device Sequence Number: 11464042
• Product Code: FPA
• UDI-Device Identifier: 05705244005495
• UDI-Public: 05705244005495
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 09/01/2022
• Device Model Number: MMT-862
• Device Lot Number: 5295169
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1