D
Patient 1
CUSTOMER REPORTED THEY HAD REC'D A BIOPSY NEEDLE LABELED 16CM BUT PACKAGE ACTUALLY CONTAINED A 20CM NEEDLE. THE DISCREPANCY WAS VISUALLY DETECTED. THEREFORE, THERE WAS NO PT INVOLVEMENT.
MAUDE MDR 259375
- MDR report key
- 259375
- Report number
- 1018233-2000-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-12-15
- Date received
- 2000-01-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 303
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- VIVIAN STEPHENS
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD BIOPSY NEEDLE | BIOPSY NEEDLE | C.R. BARD, INC. | KNW | NA | 02 441816 | 22JJ1105 | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-01-13 | 0 | 1. O |