MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-26 for MEDICHOICE KELLY HEMOSTAT, STRAIGHT, 5.5" * manufactured by Owens & Minor Distribution, Inc..
[3144040]
This pt had an open chest. They had performed multiple bedside sternotomies in an effort stabilize bleeding. The chest had been left open with sterile packing in place. The hemostats were attached to the sterile packing. When the md went to remove the hemostat, he noted that the clamp was broken. As they removed the dressing the broken piece was readily found lying amongst the remaining dressings. Discussion with critical care nurse notes that this was not the first time the hemostat clamp had broken, but she had not thought to make a report of previous incidents as they were "minor" occurrences and not in direct contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2894700 |
| MDR Report Key | 2894700 |
| Date Received | 2012-12-26 |
| Date of Report | 2012-12-26 |
| Date of Event | 2012-12-14 |
| Report Date | 2012-12-26 |
| Date Reported to FDA | 2012-12-26 |
| Date Added to Maude | 2013-01-03 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDICHOICE |
| Generic Name | INSTRUMENT, SURGICAL, HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2012-12-26 |
| Model Number | KELLY HEMOSTAT, STRAIGHT, 5.5" |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-26 |