FDA Adverse Event
Malfunction
Summary report: N
E REIN MUR 8.5MM
MDR report key: 5154243
·
Received October 15, 2015
Report
- Report Number
- 9611710-2015-30687
- Event Type
- Malfunction
- Date Received
- October 15, 2015
- Report Date
- February 27, 2014
- Manufacturer
- UNOMEDICAL SDN BHD
- Product Code
- BTR
- PMA / PMN Number
- K962389
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A). (B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE INDUSTRIAL SALES RECEIVING QC INSPECTION THE FOLLOWING DEFECT WAS OBSERVED: THE BEVEL ORIENTATION AFTER BENDING EXCEEDED THE LIMIT AND THE INFLATION LUMEN EXCEEDED 45 DEGREES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683934 | E REIN MUR 8.5MM | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | UNOMEDICAL SDN BHD | 66D1495 | 616360R001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |