FDA Adverse Event
Malfunction
Summary report: N
4FR S/L GROSHONG PICC W/SAFETY IV CATH
MDR report key: 3851831
·
Received April 11, 2014
Report
- Report Number
- 3006260740-2014-00179
- Event Type
- Malfunction
- Date Received
- April 11, 2014
- Date of Event
- March 20, 2014
- Report Date
- March 20, 2014
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K871998
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A LOT HISTORY REVIEW (LHR) OF REXA2052 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION.
Description of Event or Problem · 1
WHEN THE NURSE PULLED OUT THE CATHETER, SHE FOUND THAT THE CATHETER HAD BEEN FRACTURED. AND THEN SHE CHECKED THE CATHETER AND FOUND THE FRACTURE AT 6 CM IN THE FRONT-END OF THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221188 | 4FR S/L GROSHONG PICC W/SAFETY IV CATH | LJS | C.R. BARD, INC. (BASD) | REXA2052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |