FDA Adverse Event
Injury
Summary report: N
ENTERIFLEX FEEDING TUBE
MDR report key: 51739
·
Received November 27, 1996
Report
- Report Number
- 2242547-1996-00006
- Event Type
- Injury
- Date Received
- November 27, 1996
- Date of Event
- October 2, 1996
- Report Date
- October 29, 1996
- Manufacturer
- BIOSEARCH MEDICAL PRODUCTS, INC.
- Product Code
- FPD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
X-RAY WAS PERFORMED APPROXIMATELY 30 MINUTES AFTER PLACEMENT OF THE TUBE. THE RESULTS INDICATED THAT THE TUBE HAD BEEN INSERTED INTO THE LUNG. THE TUBE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE PATIENT HAD DEVELOPED A PNEUMOTHORAX. A CHEST TUBE WAS INSERTED TO ALLEVIATE THE SITUATION AND THE PATIENT SLOWLY RECOVERED. THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERIFLEX FEEDING TUBE | FEEDING TUBE | FPD | BIOSEARCH MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |