FDA Adverse Event
Other
Summary report: N
DEROYAL
MDR report key: 3360012
·
Received September 13, 2013
Report
- Report Number
- 1060680-2013-00007
- Event Type
- Other
- Date Received
- September 13, 2013
- Date of Event
- July 17, 2013
- Report Date
- August 20, 2013
- Manufacturer
- BENLAN INC.
- Product Code
- FPD
- PMA / PMN Number
- K100700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
DEROYAL: THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE MFR, BENLAN INC., HAS BEEN NOTIFIED OF THE ISSUE AND THEIR INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.
Description of Event or Problem · 1
THE NICU NURSES ARE CLAIMING THAT THE FEEDING TUBES HARDEN SIGNIFICANTLY AFTER BEING IN INFANTS FOR A FEW DAYS, CAUSING OESOPHAGEAL TEARS. THE TUBES WILL SLIP OUT WHICH IS A NORMAL OCCURRENCE BUT THEY THINK THAT AT THE TIME OF READJUSTING, TEARS ARE OCCURRING DUE TO THE TUBE BEING SO HARD. INFANTS EXPERIENCED TEARS BUT INJURIES WERE NOT LIFE THREATENING NOR DID THEY REQUIRE SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462147 | DEROYAL | TUBE, FEEDING | FPD | BENLAN INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |