FDA Adverse Event
Malfunction
Summary report: N
AMERITUS ENFIT ENTERAL FEEDING TUBE
MDR report key: 6678487
·
Received June 29, 2017
Report
- Report Number
- 2080225-2017-05012
- Event Type
- Malfunction
- Date Received
- June 29, 2017
- Date of Event
- May 2, 2017
- Report Date
- June 28, 2017
- Manufacturer
- KENTEC MEDICAL, INC.
- Product Code
- FPD
- UDI-DI
- 10817522012292
- PMA / PMN Number
- K100526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE SUPPLIER OF THE RAW MATERIALS THAT COMPOSES THE RADIOPAQUE PORTION OF THE TUBING, INADEQUATELY MIXED THE PROPORTIONS OF RAW MATERIALS TOGETHER, RESULTING IN THE RADIOPAQUE CAPACITY TO BE COMPROMISED. UPON COMPLAINT INVESTIGATION, THE CONTRACT MANUFACTURER OPENED A CAPA TO ESTABLISH AND IMPLEMENT PROCEDURES TO VERIFY THE RADIOPAQUE CAPACITY OF THE TUBING TO ASSURE THAT THE PROBLEM DOES NOT REOCCUR. AT THIS TIME, THE CAPA IS STILL ONGOING.
Description of Event or Problem · 1
INDWELLING FEEDING TUBE WAS NOT VISIBLE UNDER XRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460324 | AMERITUS ENFIT ENTERAL FEEDING TUBE | FEEDING TUBE | FPD | KENTEC MEDICAL, INC. | ENF-80P-40 | KS1606032 | 10817522012292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 DA | Other |