MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/8 PCC

Lot Number	5189488
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 that in the process of inserting a set it got pulled out of the connector, tubing came off from the head and was in the hand.The site location was 5 inches below belly button and the pump was laying on the table.The infusion was not in use as the issue occurred while changing the set.Reportedly, the infusions were stored in the kitchen.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.In the investigation it was found that the glue in the tubing connector was missing.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 80/8 PCC
• MDR Report Key: 8494314
• Report Number: 3003442380-2019-00974
• Device Sequence Number: 1704371
• Product Code: FPA
• UDI-Device Identifier: 05705244006072
• UDI-Public: 05705244006072
• 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: 08/01/2020
• Device Lot Number: 5189488
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1