FDA Adverse Event
Malfunction
Summary report: N
ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT
MDR report key: 2961281
·
Received February 8, 2013
Report
- Report Number
- 9611710-2013-00096
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- May 28, 2012
- Report Date
- June 22, 2012
- Manufacturer
- UNOMEDICAL SDN BHD
- Product Code
- BTR
- PMA / PMN Number
- K962389
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
BASED ON AVAILABLE INFO, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE THE PRODUCT WHOSE CUFF HAD FAILED TO DEFLATE. (B)(4).
Description of Event or Problem · 1
THIS COMPLAINT WAS RECEIVED BY (B)(4) ON (B)(6) 2012 FROM (B)(6) FOR PRODUCT REINFORCED TUBE SIZE 7.0MM. CUSTOMER COMPLAINING: "THE USER WAS NOT ABLE TO INFLATE / DEFLATE THE CUFF SMOOTHLY. IT WAS FOUND AT CUFF CHECK BEFORE USE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55116 | ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT | TUBE, TRACHAEL | BTR | UNOMEDICAL SDN BHD | 61214070IJ | 609408R001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |