MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2010-07-22 for DEBAKEY RING HANDLE BULLDOG CLAMPS - 45 DEGREE 353189 manufactured by Teleflex Medical.
[1369733]
The event is reported as: very difficult to release and close - there is a lot of resistance in movement which has caused damage to the pt vessel. The surgeon reported that when he was trying to release the ratchet, it tore the vessel in a cabg procedure. After incident, pt condition was listed as fine.
Patient Sequence No: 1, Text Type: D, B5
[8681036]
Product has not yet been received by mfr, therefore, the investigation report is incomplete at this time. A f/u investigation report will be sent when info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2010-00088 |
| MDR Report Key | 1775272 |
| Report Source | 01,06,08 |
| Date Received | 2010-07-22 |
| Date of Report | 2010-07-01 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-07-01 |
| Date Added to Maude | 2011-01-28 |
| 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 | ANGELA BROWN, MGR |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEBAKEY RING HANDLE BULLDOG CLAMPS - 45 DEGREE |
| Generic Name | BULLDOG CLAMPS |
| Product Code | FFN |
| Date Received | 2010-07-22 |
| Model Number | NA |
| Catalog Number | 353189 |
| Lot Number | MM1 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-22 |