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

Lot Number 5199709

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event 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®
• Type of Device: CONTACT DETACH G29 60/8 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8534866
• MDR Text Key: 142606632
• Report Number: 3003442380-2019-01266
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244005792
• UDI-Public: 05705244005792
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2020
• Device Lot Number: 5199709
• Date Manufacturer Received: 02/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1