FDA Adverse Event
Malfunction
Summary report: N
REPLACEMENT TUBE
MDR report key: 2830700
·
Received November 13, 2012
Report
- Report Number
- 1527460-2012-00084
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 19, 2012
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- KNT
- PMA / PMN Number
- K861323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT CODES: 1149: DEFLATION ISSUE; NOT LABELED H3: THE TESTING AND INVESTIGATION RESULTS CONFIRMED THE COMPLAINT. THE INFLATION VALVE AND VALVE BAND WERE NOT RETURNED WITH THE SAMPLE. H6: A LUER LOCK SYRINGE WAS USED FOR BALLOON INFLATION (CONTRARY TO LABELING THAT INSTRUCTS USE OF A LUER TIP SYRINGE). ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THE GASTROSTOMY TUBE'S BALLOON DEFLATED AND THE TUBE FELL OUT ON (B)(6) 2012; HOWEVER, THE INSERTION DATE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLACEMENT TUBE | KNT | ABBOTT NUTRITION | 51364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |