FDA Adverse Event
Other
Summary report: N
TUBE RECTAL 24 FR 20 INCH
MDR report key: 4003457
·
Received July 28, 2014
Report
- Report Number
- 9612030-2014-00037
- Event Type
- Other
- Date Received
- July 28, 2014
- Date of Event
- June 30, 2014
- Report Date
- June 30, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FEG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A RECTAL TUBE. THE CUSTOMER REPORTS THAT THE DEVICE DID NOT COME WITH INSTRUCTIONS ADVISING THE NURSE TO REMOVE THE CAP, THE NURSE INSERTED THE DEVICE WITH THE CAP ON AND THE CAP ALLEGEDLY STAYED INSIDE THE RECTUM. THE PATIENT WENT TO THE HOSPITAL TO HAVE THE CAP REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440062 | TUBE RECTAL 24 FR 20 INCH | RECTAL TUBE | FEG | COVIDIEN | 155731 | 409285064X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |