FDA Adverse Event
Malfunction
Summary report: N
INSET II
MDR report key: 24908159
·
Received April 17, 2026
Report
- Report Number
- 3003442380-2026-84447
- Event Type
- Malfunction
- Date Received
- April 17, 2026
- Date of Event
- March 23, 2026
- Report Date
- March 23, 2026
- Manufacturer
- UNOMEDICAL DEVICES S.A DE C.V
- Product Code
- FPA
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
NAME: YPSOMED AG, STREET: WEISSENSTEINSTRASSE 26, CITY: SOLOTHURN, COUNTRY: SWITZERLAND, POSTAL CODE: CH-4503, PHONE: (B)(6). 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 INFUSION SET WAS LEAKING AT SITE. THE EVENT OCCURRED ON (B)(6) 2026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247616 | INSET II | Set, administration, intravascular | FPA | UNOMEDICAL DEVICES S.A DE C.V | 86-060-52B6 | 6015900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |