MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-09 for ROCHESTER DEAN 8.5 44-8154 94-8154 manufactured by Buraq Surgical.
[18497159]
While inserting chest tube, the clamp was used to advance soft plastic tube into pleural cavity. Upon retrieval of the clamp; it was noticed the jaw of device was missing cone side only. Pt was taken immediately to the operating room for removal of detected piece. Action plan by (b)(4) the contract sterilizer of the kit: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023435 |
| MDR Report Key | 2379273 |
| Date Received | 2011-12-09 |
| Date of Report | 2011-12-09 |
| Date of Event | 2011-11-30 |
| Date Added to Maude | 2011-12-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHESTER DEAN 8.5 |
| Generic Name | HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2011-12-09 |
| Returned To Mfg | 2011-12-09 |
| Model Number | 44-8154 |
| Catalog Number | 94-8154 |
| Lot Number | INV1514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BURAQ SURGICAL |
| Manufacturer Address | 59C SMALL INDUSTRIAL ESTATE PO BOX 929 PUNJAB 51310 PK 51310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-09 |