MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-09 for 14 FR SHEATHED CATHETER CSC114 manufactured by Carefusion.
[1678147]
Only limited information has been provided by the customer - the customer reported that he has experienced between 4-6 incidents in which the patient sustained internal bleeding during endotracheal suctioning.
Patient Sequence No: 1, Text Type: D, B5
[8801111]
No sample was received for evaluation; therefore, we are unable to determine the exact root cause for the issue reported. Several attempts have been made to obtain further details from the end user customer in regards to this reported incident, but as of today no details have been provided. A review of the device history record for the lot number reported was reviewed and no deviations were found. Therefore, based on the limited information and no samples received, a root cause for this reported incident is currently unknown, but the preliminary investigation indicates a potential user misuse that could be caused by inserting the catheter beyond the endotracheal tube or by the use of high vacuum pressure. Both failures would be considered misuse and off label.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050001-2010-00007 |
| MDR Report Key | 1918772 |
| Report Source | 07 |
| Date Received | 2010-12-09 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-11-10 |
| Date Mfgr Received | 2010-11-30 |
| Date Added to Maude | 2012-03-15 |
| 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 |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 14 FR SHEATHED CATHETER |
| Generic Name | 14 FR SHEATHED CATHETER |
| Product Code | OFR |
| Date Received | 2010-12-09 |
| Model Number | CSC114 |
| Catalog Number | CSC114 |
| Lot Number | 09030049 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2010-12-09 |