MAUDE Adverse Event Report: TRUSTEEL; CONTACT DETACH G29 60/6 TCAP

Lot Number	UNKNOWN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that her infusion set tubing snapped right above the connecter piece while she was sleeping about a week before this report.Her blood glucose level was 300 mg/dl at the time of this event.She did not notice any damage when the package was first opened.She successfully changed out infusion set and resumed insulin on pump.No further information available.

• Brand Name: TRUSTEEL
• Common Device Name: CONTACT DETACH G29 60/6 TCAP
• MDR Report Key: 8295555
• Report Number: 3003442380-2019-00389
• Device Sequence Number: 13931161
• Product Code: FPA
• UDI-Device Identifier: 05705244014879
• UDI-Public: 05705244014879
• Combination Product (Y/N): N
• PMA/510(K) Number: K041545
• 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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 02/01/2019
• Patient Sequence Number: 1