I-PORT ADVANCE
Received Jul 15, 2026 · Event occurred Jun 11, 2026
Report 3003442380-2026-50815 · MDR key 25826671
Device
Generic name
Catheter,intravascular,therapeutic,short-term Less Than 30 Days
Manufacturer
Unomedical Devices S.a De C.vModel number
MMT-100TLot number
6004820
Product problems
- Complete Blockage
- Material Twisted/Bent
Patient
NA · Unknown
- Hyperglycemia
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED HYPERGLYCEMIA ISSUES EVENT ON (B)(6) 2026 BECAUSE CANNULA WAS FOUND BEND AND INTERRUPTED THERAPY THAT WAS TREATED BY INSULIN.
Additional Manufacturer Narrative
PATIENT COUNTRY: BRAZIL. NAME: (B)(6). STREET: (B)(6). CITY; (B)(6). STATE: (B)(6). ZIP CODE: (B)(6). COUNTRY: UNITED STATES. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. INVESTIGATION IN PROGRESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380.