MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-26 for INFLATABLE TRACHEAL TUBE, CUFF 8199 manufactured by J. T. Posey Co..
[3048970]
Customer reported the unit has the needle stuck at the 45 mark. There was no other physical damage reported. There was no patient incident of injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10318520]
The reported issue of the needle is stuck at the 45 mark was not confirmed. However, evaluation revealed the needle indicator is set at 24 and pressing the release button has no affect on the needle. The needle was inflated to 120 and holds pressure, but when pressure is released the needle only returned to 114. Therefore no readings could be taken. 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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2012-00625 |
| MDR Report Key | 2845220 |
| Report Source | 05,06 |
| Date Received | 2012-10-26 |
| Date of Report | 2012-09-25 |
| Date Mfgr Received | 2012-10-11 |
| Date Added to Maude | 2013-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SEGURA |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFLATABLE TRACHEAL TUBE, CUFF |
| Product Code | BSK |
| Date Received | 2012-10-26 |
| Returned To Mfg | 2012-10-02 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 1014679 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. T. POSEY CO. |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-26 |