MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-01-08 for RUSCH SAFETY CLEAR MAGILL/NO CUFF ET TUBE 100380025 manufactured by Teleflex Medical.
[3306750]
The event is reported as: prior to use of the product (catalog# 100380025), the doctor confirmed that the package was in good condition. When the doctor inserted the endotracheal tube into the patient and connected it to the ventilator, the ventilator alarmed. After that, the doctor found a leakage at the white line marks on the shaft of the device. The doctor changed to another brand to complete the operation successfully. No report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2013-00022 |
| MDR Report Key | 2907083 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-01-08 |
| Date of Report | 2012-12-13 |
| Date of Event | 2012-12-01 |
| Date Mfgr Received | 2012-12-13 |
| Date Added to Maude | 2013-01-31 |
| 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 | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | P.O. BOX 28 |
| Manufacturer City | KAMUNTING, PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH SAFETY CLEAR MAGILL/NO CUFF ET TUBE |
| Generic Name | NASORAL ET TUBE |
| Product Code | BSK |
| Date Received | 2013-01-08 |
| Catalog Number | 100380025 |
| Lot Number | 11LG26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-08 |