MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-10-01 for MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET C-TCCS-400 manufactured by Cook, Inc..
[1237440]
When the package was opened, the scalpel protection was gone from the scalpel. As a result, a hospital resident was cut. Injured person outcome is unknown.
Patient Sequence No: 1, Text Type: D, B5
[8371337]
Based on the visual damage to the tray, it is likely that this device was subjected to extreme shipping and handling conditions, including atypical crushing forces. The aforementioned issues contributed to the protectors coming off, and the scalpel protruding through the lidstock. Per specification, each tray is verified to ensure that the needle protectors are on the product, prior to further processing. We will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2009-00585 |
| MDR Report Key | 1491804 |
| Report Source | 01,05,08 |
| Date Received | 2009-10-01 |
| Date of Report | 2009-09-03 |
| Date of Event | 2009-09-03 |
| Date Facility Aware | 2009-09-03 |
| Report Date | 2009-09-03 |
| Date Mfgr Received | 2009-09-24 |
| Device Manufacturer Date | 2007-06-26 |
| Date Added to Maude | 2009-11-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET |
| Generic Name | BWC NEEDLE, EMERGENCY AIRWAY |
| Product Code | BWC |
| Date Received | 2009-10-01 |
| Returned To Mfg | 2009-09-29 |
| Model Number | NA |
| Catalog Number | C-TCCS-400 |
| Lot Number | F2090354 |
| ID Number | NA |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 27 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-10-01 |