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

Model Number	1000289
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 it was reported that a child patient's infusion set's tubing had snapped from the infusion set.Her blood glucose level was 107 mg/dl at the time of this event.They did not notice any damage when the package was first opened.No further information available.

• Brand Name: TRUSTEEL
• Common Device Name: CONTACT DETACH G29 60/6 TCAP
• MDR Report Key: 10216240
• Report Number: 3003442380-2020-00314
• Device Sequence Number: 14261245
• 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 Model Number: 1000289
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/01/2020
• Patient Sequence Number: 1