NT821731C, EDS 3, GEN LL, NO CATHETER
Report
- Report Number
- 2023988-2024-00040
- Event Type
- Malfunction
- Date Received
- May 24, 2024
- Date of Event
- May 8, 2024
- Report Date
- June 9, 2024
- Manufacturer
- NATUS MEDICAL INCORPORATED
- Product Code
- JXG
- PMA / PMN Number
- K162437
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). RISK REVIEW: PER DOC-035405 REV 08 RISK ANALYSIS SPREADSHEET, (RAS) - NATUS EDS 3 EXTERNAL DRAINAGE SYSTEM. HAZARD ID 4.40. CAUSE - LEAKAGE FROM THE STOPCOCK. EFFECT (HARM) - INFECTION. RESIDUAL RISK: MEDIUM. THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE BENEFIT OF USE OF THE ENTIRE PRODUCT OUTWEIGHS THE RISKS IDENTIFIED. NO RELATED CAPAS. THE CUSTOMER CONFIRMED THEY STILL HAVE THE DRAIN BUT THEY DID NOT PROVIDE THE LOT NUMBER. THE CUSTOMER WAS REQUESTED TO RETURN THE AFFECTED PRODUCT FOR EVALUATION.
FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT (B)(4). IT WAS DETERMINED THAT MDR NUMBER 2023988-2024-00038 SUBMITTED MAY 15 2024 IS A DUPLICATE OF THIS SUBMISSION. CLOSING THIS SUBMISSION AS THE INVESTIGATION DETAILS WILL BE DOCUMENTED UNDER MDR NUMBER 2023988-2024-00038 WITH REFERENCE TO NATUS COMPLAINT(B)(4))
NT821731C - PATIENTS EVD WAS LEAKING WHEN NURSE WENT TO DRAW CSF LABS. EVD LEAKING AT THE STOPCOCK. NO INJURIES.
NT821731C - PATIENTS EVD WAS LEAKING WHEN NURSE WENT TO DRAW CSF LABS. EVD LEAKING AT THE STOPCOCK. NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 657719 | NT821731C, EDS 3, GEN LL, NO CATHETER | NT821731C, EDS 3, GEN LL, NO CATHETER | JXG | NATUS MEDICAL INCORPORATED | NT821731C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |