FDA Adverse Event
Injury
Summary report: N
FLEXIFLO GASTROSTOMY TUBE
MDR report key: 407535
·
Received July 24, 2002
Report
- Report Number
- 1528738-2002-00024
- Event Type
- Injury
- Date Received
- July 24, 2002
- Date of Event
- June 24, 2002
- Report Date
- June 24, 2002
- Manufacturer
- ROSS PRODUCTS DIVISION (ABBOTT LABORATORIES)
- Product Code
- KNT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PHYSICIAN USES A 20 FR PEEL-AWAY SHEATH (NOT A COMPONENT OF THIS DEVICE) BY INSERTING THE SHEATH AND THEN PLACING THE DEVICE THROUGH THE SHEATH. THE DEVICE KINKED UP DURING PLACEMENT. PT'S STOMA WAS RUPTURED AND RESULTED IN LEAKAGE INTO THE PERITONEAL CAVITY. PHYSICIAN BELIEVES THE BALLOON IS LARGER AND THAT HE NEVER HAD PROBLEMS WITH THE MANUFACTURER'S 16 FR G-TUBE. ONE PT INVOLVED. NOTE: THE EVENT DATE GIVEN ABOVE IS APPROXIMATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIFLO GASTROSTOMY TUBE | 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES | KNT | ROSS PRODUCTS DIVISION (ABBOTT LABORATORIES) | 153 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |