FDA Adverse Event
Other
Summary report: N
PAJUNK SPROTTE 24 G
MDR report key: 2667085
·
Received December 23, 2005
Report
- Report Number
- 9611612-2005-00011
- Event Type
- Other
- Date Received
- December 23, 2005
- Date of Event
- May 20, 2005
- Report Date
- September 29, 2005
- Manufacturer
- PAJUNK GMBH
- Product Code
- BSP
- Removal / Correction Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ADVERSE EVENT TOOK PLACE IN THE (B)(6).
Description of Event or Problem · 1
PUNCTURED WITHOUT STYLET, FOLLOWED BY STRONG BONE CONTACT, LED TO SPINAL CANNULA BREAKAGE AT END OF INTRODUCER CANNULA TIP. THE STYLER IS TOTALLY STRAIGHT. DURING BONE COLLISION, THE SPINAL CANNULA WAS SHARPLY BENT INTO Z-SHAPE. SUCH CANNULA DEFORMATION WITHOUT STYLET WITHIN THE SPINAL CANNULA CAN LEAD TO CANNULA BREAKAGE. COLLISION WITH BONE MUST HAVE BEEN VERY STRONG FOLLOWED BY FURTHER MANIPULATION WITHIN PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAJUNK SPROTTE 24 G | SPROTTE CANNULA 24G/ 0.55X90MM | BSP | PAJUNK GMBH | UNK | 621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |