FDA Adverse Event
Malfunction
Summary report: N
FLEXIFLO ENTERAL FEEDING TUBE
MDR report key: 170565
·
Received May 28, 1998
Report
- Report Number
- 1528738-1998-00034
- Event Type
- Malfunction
- Date Received
- May 28, 1998
- Date of Event
- April 18, 1998
- Report Date
- April 29, 1998
- Manufacturer
- ROSS PRODUCTS DIVISION ABBOTT LABORATORIES
- Product Code
- BSS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMISSION DATE OF THIS REPORT: 7/20/1998. ON 7/8/1998, THE REPORTER CLARIFIED THE PREVIOUS STATEMENT "X-RAY REPORT SHOWED TUBE NOT IN STOMACH". THE FACILITY DOES NOT HAVE AN X-RAY TO SHOW WHERE THE TUBE WAS PLACED. THE NURSES HAD PLACED THE TUBE, REALIZED IT WAS NOT IN THE CORRECT POSITION, AND REMOVED THE TUBE PRIOR TO THE X-RAY BEING TAKEN.
Description of Event or Problem · 1
REPORTER ORIGINALLY STATED "NO BLEEDING, HEMOPTYSIS OR HEMATEMESIS NOTED." REPORTER'S REVISED MEDWATCH STATED "NO BLEEDING, CHEMOPTYSIS OR HEMATESIS NOTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIFLO ENTERAL FEEDING TUBE | 78 BSS TUBE, NASOGASTRIC | BSS | ROSS PRODUCTS DIVISION ABBOTT LABORATORIES | 473 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | NONE REPORTED. |