MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-09-10 for HUDSON SHERIDAN/HVT TRACHEAL TUBE, 8.5 5-13017 manufactured by Teleflex Medical.
[18866539]
The event is reported as: the customer alleges having difficulty in inflating the cuff of the endotracheal tube. No pt injury/involvement.
Patient Sequence No: 1, Text Type: D, B5
[19064116]
From the picture it was observed that "difficult to inflate cuff. " no other defects were observed. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The dhr (device history record) review could not be conducted since the lot number was not provided. A document assessment (fmea) was conducted and no changes were required. From the picture it was observed "difficult to inflate cuff", the complaint can not be confirmed and a conclusive root cause can not be determined since the sample was not available. Teleflex will continue to monitor and trend relating complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2013-00404 |
| MDR Report Key | 3390575 |
| Report Source | 01,08 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-08-30 |
| Date of Event | 2013-07-29 |
| Date Mfgr Received | 2013-08-30 |
| Date Added to Maude | 2013-12-09 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINO # 1316,RANCHO EL DESCANSO |
| Manufacturer City | TECATE, B.C. 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON SHERIDAN/HVT TRACHEAL TUBE, 8.5 |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 2013-09-10 |
| Catalog Number | 5-13017 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | TECATE, B.C. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-10 |