MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-17 for NEW'S TRACHEOTOMY HOOK OVER LGTH 6-1/2IN BE395 manufactured by Carefusion.
[1651000]
Several tracheotomy hooks bent during a procedure. The physician was using a? Tracheotomy hook during an emergency tracheotomy on a (b)(6) male patient with angioedema? When the hook bent. The physician requested another? Tracheotomy hook and it also bent. A total of four? Tracheotomy hooks bent before the physician switched to another product to finish the case. No samples for investigation as the bent hooks were all discarded.
Patient Sequence No: 1, Text Type: D, B5
[8902522]
An investigation was initiated into the matter of "bent" tracheotomy hook during use. The device was not available for evaluation. Without device cause for failure could not be determined or the issue confirmed. A historical complaint review was conducted with no trend found for this type of complaint on this product code. If the device is returned in the future, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1923569-2010-00003 |
| MDR Report Key | 1901334 |
| Report Source | 05 |
| Date Received | 2010-11-17 |
| Date of Report | 2010-11-17 |
| Date of Event | 2010-07-16 |
| Date Mfgr Received | 2010-10-19 |
| Date Added to Maude | 2012-01-18 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CAREFUSION 2200 INC (ST. LOUIS) |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEW'S TRACHEOTOMY HOOK OVER LGTH 6-1/2IN |
| Generic Name | TRACHEOTOMY HOOK |
| Product Code | KCH |
| Date Received | 2010-11-17 |
| Model Number | BE395 |
| Catalog Number | BE395 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-17 |