FDA Adverse Event
Malfunction
Summary report: N
SPLIT SEPTUM MICRO T-CONNECTOR
MDR report key: 19019816
·
Received April 2, 2024
Report
- Report Number
- 19019816
- Event Type
- Malfunction
- Date Received
- April 2, 2024
- Date of Event
- January 10, 2024
- Report Date
- January 25, 2024
- Manufacturer
- HUMMINGBIRD MED DEVICES INC
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
POSSIBLE DEFECTIVE HUMMI VALVE. HUMMI T-CONNECTOR IN PLACE FOR TEN DAYS, SITE LEAKING AT THE HUB. HUMMI T-CONNECTOR LEAKING AT THE SIDE OF HUMMI DRAW DEVICE INSERTION. LEAKING AT THE HUB. REACHED OUT TO KENTEC MEDICAL TO INVESTIGATE. PATIENT'S PERIPHERAL ARTERIAL LINE (PAL) STARTED BLEEDING FROM THE VALVE. HUMMI ON PAL HAD TO BE REPLACED. PATIENT WAS ON A FENTANYL DRIP BUT NEEDED A VERSED PRN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1567772 | SPLIT SEPTUM MICRO T-CONNECTOR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | HUMMINGBIRD MED DEVICES INC | NMT8046 | 23110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Female |