FDA Adverse Event
Malfunction
Summary report: N
OTW,XK,23CM, ST, SPLIT TIP, STANDARD KIT
MDR report key: 2801216
·
Received October 17, 2012
Report
- Report Number
- 3006260740-2012-00371
- Event Type
- Malfunction
- Date Received
- October 17, 2012
- Date of Event
- September 17, 2012
- Report Date
- October 4, 2012
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- MSD
- PMA / PMN Number
- K090101
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REWD0118 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT'S FROM THIS LOT NUMBER. ((B)(4)).
Description of Event or Problem · 1
HEMODIALYSIS CATHETER WAS PLACED (B)(4) 2012 AND REPLACED ON (B)(4) 2012 BECAUSE THE CUFF WAS EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OTW,XK,23CM, ST, SPLIT TIP, STANDARD KIT | MSD | C. R. BARD INC. (BASD) | REWD0118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |