D
Patient 1
CUSTOMER REPORTED THE UNIT HAS THE NEEDLE STUCK AT THE 50 MARK. THERE WAS NO OTHER PHYSICAL DAMAGE REPORTED. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.
MAUDE MDR 2845221
- MDR report key
- 2845221
- Report number
- 2020362-2012-00626
- Event key
- 0
- Event type
- 3
- Date received
- 2012-10-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARY SEGURA
- Address
- 5635 PECK RD. ARCADIA CA 91006 US
- Phone
- 626-626-6264
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INFLATABLE TRACHEAL TUBE, CUFF | J. T. POSEY CO. | BSK | 8199 | 8199 | 06030234 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-10-26 | 0 |
Event Narratives#
N
Patient 1
EVALUATION CODES: RESULTS: (OTHER) - EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE OF THE NEEDLE IS STUCK AT THE 50 MARK. HOWEVER THE NEEDLE INDICATOR IS AT 22 AND WHEN PRESSING THE RELEASE BUTTON IT HAS NO AFFECT ON THE NEEDLE. THE NEEDLE WAS INFLATED TO 120 AND IT HELD PRESSURE. WHEN THE PRESSURE WAS RELEASED THE NEEDLE ONLY RETURNED TO THE 22 MARK. THEREFORE NO READING COULD BE TAKEN DUE TO THE NEEDLE POSITION. NOTE: INSTRUCTIONS FOR USE INDICATES: INSPECT THE UNIT AND CHECK THE CUFF FOR LEAKS PRIOR TO USE. PRIOR TO INTUBATION OR EXTUBATION, WITHDRAW ALL THE AIR FROM THE CUFF WITH A SYRINGE AND CLOSE THE INFLATION LINE. THE CUFFLATOR SHOULD BE CALIBRATED ANNUALLY, OR IF THE MEASUREMENTS FALL OUTSIDE OF THE RANGE, OR IF THE NEEDLE DOES NOT INDICATE A PRESSURE READING OF ZERO WHEN NOTHING IS CONNECTED, OR IF THE UNIT IS EVER DROPPED. (B)(4).