MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-11 for V. MUELLER HEMOSTAT UNK UNKNOWN manufactured by Carefusion 2200, Inc..
[4540451]
During open heart surgery, one side of a hemostat jaw was found to be broken off after use in the procedure. After a thorough field and floor search were conducted without success, radiology was called to perform fluoroscopy. The foreign body was located and removed from the patient's thoracic cavity. There is no information for the manufacturer-address, age, serial number, model number and lot number. The device is available at nch for evaluation. The manufacturer has not been made aware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3893499 |
| MDR Report Key | 3893499 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-05-09 |
| Report Date | 2014-06-11 |
| Date Reported to FDA | 2014-06-11 |
| Date Reported to Mfgr | 2014-06-25 |
| Date Added to Maude | 2014-06-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V. MUELLER HEMOSTAT |
| Generic Name | HEMOSTAT, SURGICAL |
| Product Code | HRQ |
| Date Received | 2014-06-11 |
| Model Number | UNK |
| Catalog Number | UNKNOWN |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-11 |