FDA Adverse Event
Malfunction
Summary report: N
XPRESSO
MDR report key: 936021
·
Received April 9, 2007
Report
- Report Number
- 1223643-2007-00002
- Event Type
- Malfunction
- Date Received
- April 9, 2007
- Date of Event
- February 15, 2007
- Report Date
- March 31, 2007
- Manufacturer
- SPIRE BIOMEDICAL, INC.
- Product Code
- MSD
- PMA / PMN Number
- k013160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REPAIRED AND REMAINED IMPLANTED. ONE RED LUER WAS RETURNED TO THE MANUFACTURER AND THE INVESTIGATION REVEALED A CRACK ALONG THE PARTING LINE. WE HAVE NOT BEEN ABLE TO REPLICATE LUER CRACKING. USER/DEVICE INTERFACE WITH THE DEVICE MAY ALSO BE CONSIDERED FOR THE CRACKING OF LUERS. SPIRE WILL CONTINUE TO MONITOR FOR LUER ISSUES.
Description of Event or Problem · 1
INITIAL REPORT FROM FACILITY STATED THE RED LUER WAS CRACKED AND REPAIRED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPRESSO | LONG TERM HEMODIALYSIS CATHETER | MSD | SPIRE BIOMEDICAL, INC. | XS23SH28 | 99470016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |