FDA Adverse Event
Malfunction
Summary report: N
INSET II
MDR report key: 25148886
·
Received May 12, 2026
Report
- Report Number
- 3003442380-2026-17230
- Event Type
- Malfunction
- Date Received
- May 12, 2026
- Date of Event
- April 13, 2026
- Report Date
- April 14, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A DE C.V
- Product Code
- FPA
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
NAME: YPSOMED AG, COUNTRY: SWITZERLAND, STREET: WEISSENSTEINSTRASSE 26, CITY: SOLOTHURN, ZIP CODE: CH-4503. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. 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.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT INFUSION SET CANNULA WAS BENT ON (B)(6) 2026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174009 | INSET II | Set, administration, intravascular | FPA | UNOMEDICAL DEVICES S.A DE C.V | 86-046-52B6 | 6015291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |