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

Lot Number 5215332

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient stated that the needle broke off and it stayed inside under her skin.Reportedly, needle was still under her skin and will have to be removed by a surgeon.(surgery not scheduled at this time).The patient stated she did not notice the needle in her body until her bg went up and she went to remove the infusion set.Cust states this is the second time this has happened.The infusion set was in use for three days, however, ifu recommend max use of the infusion set for 48 hours.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: 8380968
• MDR Text Key: 137506314
• Report Number: 3003442380-2019-00513
• 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: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/01/2021
• Device Lot Number: 5215332
• Date Manufacturer Received: 10/17/2018
• Type of Device Usage: N
• Patient Sequence Number: 1