FDA Adverse Event
Summary report: N
BULLDOG
MDR report key: 1860591
·
Received September 28, 2010
Report
- Report Number
- 1860591
- Date Received
- September 28, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 28, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDF
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
DURING OPEN HEART PROCEDURE (CABG), THE SURGEON PLACED THE FIRST STITCH ONTO THE GRAFT USING THE NEEDLE HOLDER. WHEN HE WENT TO PICK UP THE NEEDLE FOR THE NEXT STITICH, THE NEEDLE HOLDER WOULD NOT GRASP THE NEEDLE. UPON CLOSER EXAMINATION, IT WAS NOTED THAT A SMALL PIECE OF METAL WAS MISSING FROM THE GRASPING PART OF THE NEEDLE HOLDER. EXHAUSTIVE SEARCH OF THE PATIENT'S SURGICAL AREA WAS DONE INCLUDING: MANUAL, RADIOLOGY, AND USE OF A STERILE MAGNET ACROSS THE FIELD. THE METAL PIECE COULD NOT BE LOCATED. DISCLOSURE WAS MADE TO PATIENT/FAMILY.THERE MUST HAVE BEEN A SMALL FRACTURE IN THE METAL OF THE NEEDLE HOLDER THAT WAS NOT DETECTABLE BY THE NAKED EYE DURING ROUTINE CLEANING OR BY THE ROUTINE PM'S WE HAVE DONE ON THE EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BULLDOG | NEEDLE HOLDER | GDF | TELEFLEX MEDICAL | 511136 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |