MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/10 PCC

Lot Number 5221262

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient's father reported that the infusion set was inserted, and manual injection was given to the patient.After two days of infusion set use, the patient had lunch and his blood glucose level started to go up.His blood glucose level was 550 mg/dl when the father took the old infusion set off to replace it.It was found that the needle was not attached to the set and the entire needle broke off into the patient's body.The patient was taken to the emergency room and was subsequently, admitted to the hospital to get the needle removed with blood glucose level at around 120 mg/dl.The patient received medical treatment in the form of a surgery to remove the needle that had fractured inside the patient's body.The infusion set insertion location was in upper butt area.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Type of Device: CONTACT DETACH G29 80/10 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8630576
• MDR Text Key: 145742928
• Report Number: 3003442380-2019-01485
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006034
• UDI-Public: 05705244006034
• 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: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2021
• Device Lot Number: 5221262
• Date Manufacturer Received: 04/17/2019
• Type of Device Usage: N
• Patient Sequence Number: 1