FDA Adverse Event
Malfunction
Summary report: N
FLEXIFLO ENTERAL FEEDING TUBE
MDR report key: 394543
·
Received May 10, 2002
Report
- Report Number
- 1528738-2002-00015
- Event Type
- Malfunction
- Date Received
- May 10, 2002
- Date of Event
- April 11, 2002
- Report Date
- April 23, 2002
- Manufacturer
- ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
- Product Code
- BSS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT REQUIRED THE DEVICE TO BE INSERTED. MULTIPLE ATTEMPTS WERE MADE TO PASS THE DEVICE. X-RAYS SHOWED THE DEVICE WAS NOT IN THE CORRECT POSITION. DEVICE WAS REMOVED WITH THE STYLET STILL INSIDE THE DEVICE. WHEN REMOVED, IT WAS FOUND THAT THE STYLET HAD PUNCTURED THE DEVICE. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED.
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 | 83 YR | Other |