NT821731C, EDS 3, GEN LL, NO CATHETER
Report
- Report Number
- 2023988-2023-00049
- Event Type
- Injury
- Date Received
- December 13, 2023
- Date of Event
- October 18, 2023
- Report Date
- February 26, 2024
- Manufacturer
- NATUS MEDICAL INCORPORATED
- Product Code
- JXG
- PMA / PMN Number
- K162437
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
REF TO RES# 93550 PRODUCT RECALL. IT HAS BEEN CONFIRMED THAT THE AFFECTED PART WILL NOT BE RETURNED FOR EVALUATION. LOT NUMBER OF THE PART WAS NOT PROVIDED. FURTHER INVESTIGATION TO BE CARRIED OUT.
FOLLOW UP REPORT 001 REF COMPLAINT #(B)(4) REF TO RES# 93550 PRODUCT RECALL. IT HAS BEEN CONFIRMED THAT THE AFFECTED PART WILL NOT BE RETURNED FOR EVALUATION. LOT NUMBER OF THE PART WAS NOT PROVIDED. RISK REVIEW: PER DOC-035405 REV 07 RISK ANALYSIS SPREADSHEET, (RAS) - NATUS EDS 3 EXTERNAL DRAINAGE SYSTEM, HAZARD ID 3.7. CAUSE - PATIENT REACTION DUE TO BIO CONTAMINANTS OF EDS 3 SYSTEM. EFFECT (HARM) - INFECTION. RESIDUAL RISK - MEDIUM. THE HAZARD IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS IS MAINLY ASSOCIATED WITH PATIENT HAVING A BIOLOGICAL REACTION. THE DEVICE IS STERILE AND PACKED IN MANUFACTURING. THE DEVICE IS TO BE USED IN STERILE CONDITION AND THE USER MANUAL CONTAINS INFORMATION ABOUT PROPER USAGE. IN ADDITION, TECHNIQUES LIMITING CROSS CONTAMINATION ARE ALREADY IN PLACE IN THE ENVIRONMENT FOR USE. NO DEVICE HISTORY REVIEW AVAILABLE FOR THIS PRODUCT. NO ASSOCIATED CAPAS FOUND. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 0 CONFIRMED COMPLAINTS, GIVING A FAILURE RATE OF 0.00%. REVIEW OF MEDICAL DEVICE HAZARD ANALYSIS SHOWS INCIDENT TO IDENTIFY AS AN ACCEPTABLE RISK. DEPOT REPAIR COULD NOT CONFIRM THE FAILURE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FINAL REVIEW AND APPROVAL OF INVESTIGATION DETAILS TO BE CARRIED OUT BEFORE FINAL CLOSURE.
FOLLOW UP REPORT 002 REF COMPLAINT #(B)(4) REF TO RES# 93550 PRODUCT RECALL. FINAL REVIEW AND APPROVAL OF INVESTIGATION DETAILS WAS CARRIED OUT AND THIS COMPLAINT CASE IS NOW CLOSED. THE AFFECTED PART WAS NOT RETURNED FOR EVALUATION. FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: SAN DIEGO/EDS PRODUCTS/NO RETURN OF DEVICE FOR EVALUATION.
NATUS EDS3 DRAINAGE SYSTEM & COLLECTION BAG - WE TRANSITIONED TO USING THE NATUS EVD PRODUCT MARCH 2023. SINCE JUNE WE HAVE SEEN FIVE MENINGITIS INFECTIONS (PREVIOUS INCIDENCE 1 OR 2 A YEAR) IN EVD PATIENTS. UNFORTUNATELY, WE DO NOT RECORD THE SERIAL OR LOT NUMBERS. THESE CASES HAVE OCCURRED DURING A PERIOD WHERE WE WERE USING YOUR DEVICES, INCLUDING LOT NUMBERS SUBJECT TO YOUR VOLUNTARILY RECALL 11/29/2023. PATIENT EVD INSERTED ON (B)(6) 2023 AND PATIENT MET NHSN CRITERIA FOR CNS-MENINGITIS ON (B)(6) 2023, CSF CULTURE GREW E.COLI, STREPTOCOCCUS VIRIDANS AND ENTEROCOCCUS FAECALIS. REVISION/MEDICAL INTERVENTION WAS REQUIRED.
NATUS EDS3 DRAINAGE SYSTEM & COLLECTION BAG - WE TRANSITIONED TO USING THE NATUS EVD PRODUCT (B)(6) 2023. SINCE JUNE WE HAVE SEEN FIVE MENINGITIS INFECTIONS (PREVIOUS INCIDENCE 1 OR 2 A YEAR) IN EVD PATIENTS. UNFORTUNATELY, WE DO NOT RECORD THE SERIAL OR LOT NUMBERS. THESE CASES HAVE OCCURRED DURING A PERIOD WHERE WE WERE USING YOUR DEVICES, INCLUDING LOT NUMBERS SUBJECT TO YOUR VOLUNTARILY RECALL (B)(6) 2023. PATIENT EVD INSERTED (B)(6) 23 AND PATIENT MET NHSN CRITERIA FOR CNS-MENINGITIS ON (B)(6) 23, CSF CULTURE GREW E.COLI, STREPTOCOCCUS VIRIDANS AND ENTEROCOCCUS FAECALIS. REVISION/MEDICAL INTERVENTION WAS REQUIRED.
NATUS EDS3 DRAINAGE SYSTEM & COLLECTION BAG - WE TRANSITIONED TO USING THE NATUS EVD PRODUCT (B)(6) 2023. SINCE JUNE WE HAVE SEEN FIVE MENINGITIS INFECTIONS (PREVIOUS INCIDENCE 1 OR 2 A YEAR) IN EVD PATIENTS. UNFORTUNATELY, WE DO NOT RECORD THE SERIAL OR LOT NUMBERS. THESE CASES HAVE OCCURRED DURING A PERIOD WHERE WE WERE USING YOUR DEVICES, INCLUDING LOT NUMBERS SUBJECT TO YOUR VOLUNTARILY RECALL (B)(6) 2023. PATIENT EVD INSERTED (B)(6) 23 AND PATIENT MET NHSN CRITERIA FOR CNS-MENINGITIS ON (B)(6) 23, CSF CULTURE GREW E.COLI, STREPTOCOCCUS VIRIDANS AND ENTEROCOCCUS FAECALIS. REVISION/MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1303966 | 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 | 41 YR | Male | Other |