| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD MAGNUM BIOPSY NEEDLE | BIOPSY NEEDLE | BARD PERIPHERAL VASCULAR | KNW | NA | MN1820 | 22LO3963 | N | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2006-11-22 | 0 | 1. R |
Patient 1
IT WAS REPORTED THAT FOLLOWING A PERINEAL PROSTATE BIOPSY, THE PATIENT DEVELOPED A PERINEAL INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE ISSUE RESOLVED WITHOUT ANY FURTHER COMPLICATIONS BEING REPORTED. THE DOCTOR'S OFFICE MANAGER STATED THE DOCTOR WOULD NOT BE RESPONDING TO OUR REQUEST FOR ADDITIONAL INFORMATION AS THEY DID NOT REMEMBER THE PATIENT'S NAME. SHE FURTHER STATED THE PATIETN'S INFECTION WAS TOTALLY UNRELATED TO THE BIOPSY NEEDLES.
Patient 1
THE PRODUCTS IN THIS LOT NUMBER WERE PROCESSED WITH ETHYLENE OXIDE IN A CYCLE WHICH HAS BEEN VALIDATED TO ANSI/AAMI/ISO GUIDELINES FOR A STERILITY ASSURANCE LEVEL (SAL) LEVEL OF 10 (-6). ALL PRODUCTS ARE CONSIDERED STERILE UNLESS PACKAGE INTEGRITY IS COMPROMISED. ALL PRODUCTS HAVE BEEN MANUFACTURED IN ACCORDANCE WITH FDA QUALITY SYSTEMS REGULATIONS AND CONFORM TO ALL INTERNAL SPECIFICATIONS. ALL BIOLOGICAL INDICATOR TESTING HAVE BEEN SUCCESSFULLY COMPLETED. THE SEVEN UNITS RETURNED WERE VISUALLY EXAMINED AND THE PACKAGING WAS INTACT WITH NO OBVIOUS DEFECTS NOTED. THE PACKAGING INTEGRITY HAD NOT BEEN COMPROMISED. THE EXACT CAUSE OF THE PATIENT'S INFECTION COULD NOT BE DETERMINED, HOWEVER, IT IS NOT LOGICAL TO ASSUME IT RESULTED FROM THE USE OF A STERILE DEVICE.