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

Lot Number	5247354
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set was kinked and stressed.Prior to hospitalization, he self-treated with a correction bolus.His blood glucose was 1200 mg/dl and he experienced diabetic ketoacidosis.During the stay in the hospital, he received antibiotics, oxygen and dome unspecified drug via intravenous drip which resolved the issue.He was hospitalized for nine days.No further information available.

• Brand Name: TRUSTEEL
• Common Device Name: CONTACT DETACH G29 60/6 TCAP
• MDR Report Key: 8450831
• Report Number: 3003442380-2019-00675
• Device Sequence Number: 13502202
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 07/01/2021
• Device Lot Number: 5247354
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/26/2019
• Patient Sequence Number: 1