FDA Adverse Event
Other
Summary report: N
ENTRIFLEX FEEDING TUBE
MDR report key: 3817524
·
Received May 5, 2014
Report
- Report Number
- 9612030-2014-00027
- Event Type
- Other
- Date Received
- May 5, 2014
- Report Date
- April 29, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FPD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
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)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FEEDING TUBE AND RECEIVED A CONTAMINATED STICK. THE CUSTOMER REPORTS THAT A KAOFEED TUBE WAS INSERTED INTO THE PATIENT. THE PLACEMENT WAS VERIFIED BY CXR. UPON ATTEMPTING TO REMOVE THE GUIDEWIRE, THE CAP ON THE GUIDEWIRE CAME OFF AND A STAFF MEMBER WAS POKED BY THE SHARP METAL WIRE. THE GUIDEWIRE WAS UNABLE TO BE REMOVED EVEN WHEN TRYING TO REMOVE IT WITH FORCEPS. THE TUBE WAS THEN DISCONTINUED AND A NEW KAOFEED TUBE WAS INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267926 | ENTRIFLEX FEEDING TUBE | FEEDING TUBE | FPD | COVIDIEN | 8884720825 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |