FDA Adverse Event
Malfunction
Summary report: N
RUSCH CRYSTAL CLEAR TRACHEOSTOMY TUBE CUFF 7.5
MDR report key: 2091137
·
Received May 9, 2011
Report
- Report Number
- 8040412-2011-00065
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 15, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- JOH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE BALLOON HAD AN AIR LEAKAGE. COMPLAINT STATES THAT THE ALLEGED LEAK OCCURRED DURING A FUNCTIONALITY TEST PRIOR TO PATIENT USE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH CRYSTAL CLEAR TRACHEOSTOMY TUBE CUFF 7.5 | TRACHEOSTOMY TUBE CUFF | JOH | TELEFLEX MEDICAL | NA | 10FE24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |