MAUDE Adverse Event Report: INSET¿; INSET I 60/6 GREY

Lot Number	5153787
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
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient had a tubing issue as it was cracked/broken.The tubing came apart from the infusion set prior to use.In the investigation it was found that the glue was missing from the tubing connector (glue was misplaced on the tubing connector).No further information available.

• Brand Name: INSET¿
• Common Device Name: INSET I 60/6 GREY
• MDR Report Key: 8467966
• Report Number: 3003442380-2019-00802
• Device Sequence Number: 13831996
• Product Code: FPA
• UDI-Device Identifier: 05705244006874
• UDI-Public: 05705244006874
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• 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: 08/01/2019
• Device Lot Number: 5153787
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 03/30/2019
• Patient Sequence Number: 1