FDA Adverse Event
Malfunction
Summary report: N
BN MAR BIOP ASP NDL 8X4 LL X10
MDR report key: 3717272
·
Received February 4, 2014
Report
- Report Number
- 1282497-2014-00011
- Event Type
- Malfunction
- Date Received
- February 4, 2014
- Date of Event
- December 20, 2013
- Report Date
- January 29, 2014
- Manufacturer
- COVIDIEN
- Product Code
- KNW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 02/03/2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
HOLD SBF IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A BIOPSY NEEDLE. THE CUSTOMER REPORTS THAT DURING A BONE MARROW BIOPSY, SEPARATION OF THE HANDLE/SLEEVE AND TROCAR. IT WAS IMPOSSIBLE TO WITHDRAW THE TROCAR FROM THE ILIUM. THE CUSTOMER REPORTS THAT THEY NEEDED TO PERFORM AN ORTHOPEDIC SURGERY TO REMOVE THE TROCAR. ANTIBIOTICS ADMINISTERED TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 72706 | BN MAR BIOP ASP NDL 8X4 LL X10 | BIOPSY NEEDLE | KNW | COVIDIEN | 8881247087 | 130020065X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |