FDA Adverse Event
Malfunction
Summary report: N
KNT TUBES, GASTROINTESTINAL
MDR report key: 7273830
·
Received February 15, 2018
Report
- Report Number
- 1820334-2018-00500
- Event Type
- Malfunction
- Date Received
- February 15, 2018
- Date of Event
- November 9, 2015
- Report Date
- February 15, 2018
- Manufacturer
- COOK INC
- Product Code
- KNT
- UDI-DI
- 00827002084179
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BRAND NAME- ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET. (B)(4). THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL CAP(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
IT WAS REPORTED THAT WHEN THE PATIENT RETURNED HOME AFTER IMPLANTATION OF THE CATHETER, THEY FOUND THAT THE CATHETER AND HUB JUNCTION WERE LEAKING. THE PATIENT RETURNED TO THE HOSPITAL TO HAVE THE CATHETER REPLACED, BUT THERE WERE NO FURTHER INJURIES ASIDE FROM THIS ADDITIONAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119237 | KNT TUBES, GASTROINTESTINAL | KNT | COOK INC | 00827002084179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |