FDA Adverse Event
Malfunction
Summary report: N
E HVLP MUR ICU KCC 8.0MM
MDR report key: 5890753
·
Received August 19, 2016
Report
- Report Number
- 9611710-2016-00107
- Event Type
- Malfunction
- Date Received
- August 19, 2016
- Report Date
- July 29, 2016
- Manufacturer
- UNOMEDICAL SDN BHD
- Product Code
- BTR
- PMA / PMN Number
- K050803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON: AUGUST 19, 2016. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD LEAKS UPON AUSCULTATION FOR PLACEMENT. THE PATIENT WAS EXTUBATED AND RE-INTUBATED WITH A NEW DEVICE OF THE SAME TYPE AND SIZE. NO PATIENT HARM WAS REPORTED DUE TO THIS DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540779 | E HVLP MUR ICU KCC 8.0MM | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | UNOMEDICAL SDN BHD | 35216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |