FDA Adverse Event
Malfunction
Summary report: N
SAFESTEP 22GX3/4
MDR report key: 1371242
·
Received February 6, 2009
Report
- Report Number
- 3006260740-2009-00047
- Event Type
- Malfunction
- Date Received
- February 6, 2009
- Date of Event
- October 14, 2008
- Report Date
- January 19, 2009
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- FPA
- PMA / PMN Number
- K040527
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT OF A LEAK WAS CONFIRMED, AND WILL BE CONSIDERED MANUFACTURING RELATED. A LEAK WAS DETECTED AT EACH NEEDLE HUB. THE LEAK PATH WAS LOCATED ALONG THE INTERFACE BETWEEN THE PROXIMAL END OF THE NEEDLE AND THE EXTENSION SET TUBING. A CHR OF LOT #D817535 SHOWED FOUR OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT. (202874, 204950, 208615, 208617).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRODUCT LEAKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFESTEP 22GX3/4 | FPA | C. R. BARD INC. (BASD) | D817535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |