FDA Adverse Event
Malfunction
Summary report: N
COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY
MDR report key: 7523097
·
Received May 17, 2018
Report
- Report Number
- 1820334-2018-01480
- Event Type
- Malfunction
- Date Received
- May 17, 2018
- Date of Event
- April 22, 2015
- Report Date
- May 17, 2018
- Manufacturer
- COOK INC
- Product Code
- MPB
- UDI-DI
- 00827002350892
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
COMMON NAME: MPB CATHETER, HEMODIALYSIS, NON-IMPLANTED. PRODUCT CODE: MPB. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THE COOK TURBO-FLO HD HEMODIALYSIS CATHETER WAS BEING USED FOR CONTINUOUS RENAL REPLACEMENT THERAPY THROUGH THE RIGHT SUBCLAVIAN. THE DILATOR TIP BROKE DURING INSERTION. HOWEVER, THE PRODUCT PROBLEM DID NOT RESULT IN ANY DEVICE PIECES BEING LEFT WITHIN THE PATIENT OR OTHER SERIOUS INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 366595 | COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY | MPB | COOK INC | G35089 | 00827002350892 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |