MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-11-07 for INFLATABLE TRACHEAL TUBE CUFF 8199 manufactured by J. T. Posey Co..
[17977374]
Customer reported that the needle will not rest at zero when pressure is released. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[18245820]
Results - evaluation of the returned product confirmed the reported issue that the needle will not rest at zero when pressure is released. The needle pointer is at 24, but moves up when the inflation bulb is squeezed and holds pressure. When the pressure is released the needle returns to 24. No readings were taken due to the position of the needle. Visual findings revealed the perflex face plate is chipped, rubber protective ring is missing, and needle is bent. 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 | 2020362-2012-00635 |
| MDR Report Key | 2865306 |
| Report Source | 08 |
| Date Received | 2012-11-07 |
| Date of Report | 2012-10-10 |
| Date Mfgr Received | 2012-10-10 |
| Date Added to Maude | 2013-02-13 |
| 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 |
| Manufacturer G1 | J. T. POSEY CO. |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91006 |
| 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 | 2012-11-07 |
| Returned To Mfg | 2012-10-16 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 1015133 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-11-07 |