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

Lot Number	5231173
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 the united states.The patient's mother reported, her son's infusion set tubing separated from the connector piece at two different times.The issue resolved by inserting a new infusion set and resuming insulin.After first detachment, the patient blood glucose level was 189 mg/dl.No further information available.

• Brand Name: TRUSTEEL
• Common Device Name: CONTACT DETACH G29 60/6 TCAP
• MDR Report Key: 8188572
• Report Number: 3003442380-2018-00131
• Device Sequence Number: 14113598
• 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 Expiration Date: 05/01/2021
• Device Lot Number: 5231173
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/21/2018
• Patient Sequence Number: 1