MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 60/8 PCC

Lot Number	5199709
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient's mother reported that she inserted the infusion set on her daughter and the issue occurred 2 days later.The patients blood glucose level went up to 16 and 24 mmol/l that day and when she removed the set she found that the needle was missing.Set was inserted on her buttock.Reportedly, there was no redness and discharge, but the patient had pain at the site.The doctor at the hospital recommended a plastic surgeon to do the surgery and the patient had to undergo surgery.In the investigation it was found that the picture of the steel introducer needle was broken inside to the skin of the patient.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: CONTACT DETACH G29 60/8 PCC
• MDR Report Key: 8534866
• Report Number: 3003442380-2019-01266
• Device Sequence Number: 2457767
• Product Code: FPA
• UDI-Device Identifier: 05705244005792
• UDI-Public: 05705244005792
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• 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: 07/01/2020
• Device Lot Number: 5199709
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1