FDA Adverse Event
Malfunction
Summary report: N
LHK-,BASC,OPCO
MDR report key: 21574808
·
Received March 11, 2025
Report
- Report Number
- 3015910259-2025-00022
- Event Type
- Malfunction
- Date Received
- March 11, 2025
- Date of Event
- February 10, 2025
- Report Date
- March 9, 2026
- Manufacturer
- MEDLINE INDUSTRIES, LP - NAMIC
- Product Code
- OES
- UDI-DI
- 10193489148725
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPDATE TO E1: NAME AND ADDRESS. UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE DEVICE WAS "LEAKING COMING FROM THE SYRINGE AT THE CONNECTION PORT". TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 0
SYRINGE DISCONNECTED FROM MANIFOLD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1202811 | LHK-,BASC,OPCO | OES | MEDLINE INDUSTRIES, LP - NAMIC | 0000134097 | 10193489148725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |