FDA Adverse Event
Malfunction
Summary report: N
IV EXT SET,SMBORE EXT,8,M LUERLOCK,1NF
MDR report key: 23757191
·
Received December 9, 2025
Report
- Report Number
- 1417592-2025-00691
- Event Type
- Malfunction
- Date Received
- December 9, 2025
- Date of Event
- November 11, 2025
- Report Date
- December 29, 2025
- Manufacturer
- MEDLINE INDUSTRIES LP
- Product Code
- FPA
- UDI-DI
- 10197344098668
- PMA / PMN Number
- K242126
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT DURING ADMINSTRATION OF MEDICATION, THE LIQUID BEGAN "DRIPPING OUT OF THE CONNECTION". NO SERIOUS INJURY WAS REPORTED RELATED TO THIS INCIDENT. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED,
Additional Manufacturer Narrative · 0
UPDATED SECTIONS D9, G3, G6, H2, H3, H6.
Description of Event or Problem · 0
MEDICATION DRIPPED OUT OF THE EXTENSION SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2771727 | IV EXT SET,SMBORE EXT,8,M LUERLOCK,1NF | FPA | MEDLINE INDUSTRIES LP | BQ250456501 | 10197344098668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Other |