FDA Adverse Event
Injury
Summary report: N
BARD-PARKER
MDR report key: 4231685
·
Received October 13, 2014
Report
- Report Number
- 1836161-2014-00058
- Event Type
- Injury
- Date Received
- October 13, 2014
- Date of Event
- September 12, 2014
- Report Date
- October 6, 2014
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- GES
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BLADE IS DULL AND BARBED. SURGEON TRIED OTHERS FROM THIS LOT WITH THE SAME RESULT. NOT ACCEPTABLE FOR FINE OPEN HEART SURGERY. ALL LOT REMOVED FROM SPH STOCK AND READY FOR PICKUP BY VENDOR. THE SURGEONS WOULD LIKE FEEDBACK FROM THE COMPANY. SURGEON STATED: THE 11 BLADE WAS TO USE TO MAKE A CORONARY ARTERIOTOMY, IT TORN THE VESSEL. I HAVE TO REPAIR IT, NO OTHER ADVERSE OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 645927 | BARD-PARKER | CARBON RIB-BACK BLADES SIZE 11, STERILE | GES | ASPEN SURGICAL PRODUCTS, INC. | 371111 | 0048868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |