FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 2181318
·
Received July 19, 2011
Report
- Report Number
- 2181318
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 19, 2011
- Manufacturer
- KIMBERLY-CLARK
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
A PT WAS IN THE PEDIATRIC ICU (PICU) FOR PROCEDURAL SEDATION FOR THE PLACEMENT OF A 16 FRENCH MIC-KEY BUTTON AND THE REMOVAL OF AN EXISTING GASTRIC JEJUNAL (G-J) TUBE. THE PT WAS G-TUBE DEPENDENT SECONDARY TO SEVERE REFLUX. THE PT WAS SEDATED WITH PROPOFOL. THE G-TUBE THE PT'S FAMILY BROUGHT WITH THEM FROM THE PHYSICIAN'S OFFICE HAD A LEAK IN THE BALLOON AND WAS UNUSABLE. A 14 FRENCH MIC-KEY BUTTON WAS USED IN ITS PLACE. THERE WERE TWO FAILED ATTEMPTS BEFORE THE THIRD PLACEMENT WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL G TUBE/KIT | KNT | KIMBERLY-CLARK | * | AA0179N07 | |
| 2 | * | MIC-KEY* LOW-PROFILE GASTROSTOMY FEEDING TUBE | KNT | KIMBERLY-CLARK | * | AA0333F08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 MO | NO OTHER THERAPIES |