MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 60/6 PCC

Lot Number 5278527

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).It was reported that the patient's mother inserted the infusion set on (b)(6) 2019 at 08:00 pm and it was used till (b)(6) 2019 without any complications or relevant problem.Reportedly, the patient used the infusion set till 09:00 pm on (b)(6) 2019.Therefore, there were no site issues and the infusion set had been in use for 48 hours.On the same day ((b)(6) after 09:00 pm), the patient's mother noticed hardened insertion site and fractured needle at the time of removal of the set.Further, she could not see the needle parts at the buttock's (insertion site).Subsequently, at 10:15 pm, the patient called the hotline and at 11:00 pm, and drove to the hospital.Subsequently, the patient was hospitalized, and the doctor arranged an x-ray for the patient, and it was detected that infusion set needle was 2 cm inside buttocks tissue.Therefore, the doctor had arranged a surgery date for (b)(6) 2019, after which the patient was released from the hospital and went back home.The patient's mother inserted new infusion set at different part of buttocks, because the patient did not have another available site, which was appropriate.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Type of Device: CONTACT DETACH G29 60/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9562274
• MDR Text Key: 182597426
• Report Number: 3003442380-2020-00106
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• 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: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2022
• Device Lot Number: 5278527
• Date Manufacturer Received: 11/27/2019
• Type of Device Usage: N
• Patient Sequence Number: 1