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

Lot Number	5192531
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
(b)(4).Event occurred in (b)(6).The patient reported that some time ago he noticed that the tubing detached from the quick release right after he opened sterile box with the set.Reportedly, the infusions were not stored in place where they could have been exposed to extreme temperatures, stored the sets in wardrobe at room temperature.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 46/6 PCC
• MDR Report Key: 8538669
• Report Number: 3003442380-2019-01229
• Device Sequence Number: 400628
• Product Code: FPA
• UDI-Device Identifier: 05705244005495
• UDI-Public: 05705244005495
• 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: 05/01/2020
• Device Lot Number: 5192531
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1