MAUDE Adverse Event Report: SURE-T PARADIGM; CONTACT DETACH G29 80/10 PCC

Model Number	MMT-886
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 the united states.It was reported by the patient that she had a set that came out from her body while she was changing clothes.The site location was her abdomen and the pump was located in her bra.The infusion had been used for less than 24 hours.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: SURE-T PARADIGM
• Common Device Name: CONTACT DETACH G29 80/10 PCC
• MDR Report Key: 10625020
• Report Number: 3003442380-2020-00411
• Device Sequence Number: 2554578
• Product Code: FPA
• UDI-Device Identifier: 05705244006034
• UDI-Public: 05705244006034
• 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: 04/01/2023
• Device Model Number: MMT-886
• Device Lot Number: 5317641
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1