FDA Adverse Event
Malfunction
Summary report: N
POWERGLIDE MIDLINE CATHETER, 20G 10CM
MDR report key: 3851802
·
Received April 11, 2014
Report
- Report Number
- 3006260740-2014-00181
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- March 20, 2014
- Report Date
- March 21, 2014
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- FOZ
- PMA / PMN Number
- K121073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE IS BEING RETAINED BY THE REPORTING FACILITY. A LOT HISTORY REVIEW (LHR) OF REXL0857 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
DURING TRAINING FOR POWERGLIDE INSERTIONS AN UNSUCCESSFUL ATTEMPT WAS MADE. WHEN THE NURSE WITHDREW THE DEVICE THE SAFETY MECHANISM HAD NOT BEEN ACTIVATED THEREFORE SHEARING OF THE CATHETER OCCURRED. A FRAGMENT OF APPROXIMATELY 4CM WAS RETAINED IN THE PATIENT'S SUBCUTANEOUS TISSUE AS REVEALED BY X-RAY. MD NOTIFIED OF OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221235 | POWERGLIDE MIDLINE CATHETER, 20G 10CM | FOZ | C.R. BARD, INC. (BASD) | REXL0857 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |