FDA Adverse Event
Malfunction
Summary report: N
SAFESTEP 22G X 3/4 STRAIGHT
MDR report key: 1366077
·
Received March 20, 2009
Report
- Report Number
- 3006260740-2009-00119
- Event Type
- Malfunction
- Date Received
- March 20, 2009
- Date of Event
- January 13, 2009
- Report Date
- March 2, 2009
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- FPA
- PMA / PMN Number
- K040527
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT OF A LEAK WAS UNCONFIRMED, AS THE REPORTED INCIDENT COULD NOT BE REPLICATED. THE EXTENSION SET TUBING WAS FLUSHED WITH WATER AND WAS PATENT TO INFUSION; HOWEVER, NO LEAKS WERE DETECTED IN THE COMPLAINT SAMPLE. A CHR OF LOT# D818637 SHOWED FOUR OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT. (205901, 207723, 213020, AND 213034).
Description of Event or Problem · 1
FAULTY PORT NEEDLE; IV FLUID LEAKING FROM PLASTIC (TOP OF PORT NEEDLE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFESTEP 22G X 3/4 STRAIGHT | FPA | C.R. BARD, INC. (BASD) | D818637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |