FDA Adverse Event
Malfunction
Summary report: N
EXCHANGE TRANSFUSION TRAY - NEONATAL
MDR report key: 20425781
·
Received October 11, 2024
Report
- Report Number
- 20425781
- Event Type
- Malfunction
- Date Received
- October 11, 2024
- Date of Event
- June 12, 2024
- Report Date
- July 31, 2024
- Manufacturer
- MARIAN MEDICAL, 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
EXCHANGE TRANSFUSION TRAY WITH INDIVIDUALLY PACKAGED SHUTTLE SET WITH SLIP TIP CONNECTION CAME LOOSE WHEN ATTEMPTING TO SETUP THE SHUTTLE SET. THIS PIECE SHOULD BE PERMANENTLY CONNECTED. ONCE LOOSE, PIECE WOULD NOT RECONNECT. STAFF DISCARDED THAT PORTION OF SHUTTLE SET AND UTILIZED AN EXTERNAL STOPCOCK STOCKED WITHIN HOSPITAL TO PERFORM EXCHANGE TRANSFUSION. NEW LOT # (3214-061424) DOES NOT SEEM TO HAVE THIS ISSUE. IT SEEMS TO BE LIMITED TO OLD LOT # OF 2734-010824 (WITH INDIVIDUALLY PACKAGED SHUTTLE SET LOT # OF 19808).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294098 | EXCHANGE TRANSFUSION TRAY - NEONATAL | SET, ADMINISTRATION, INTRAVASCULAR | FPA | MARIAN MEDICAL, INC | 2734-010824, 19808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |