FDA Adverse Event
Malfunction
Summary report: N
BROVIAC 4.2 FR SL CVC CUTDOWN TRAV WITH SURECUFF TISSUE IN
MDR report key: 3831911
·
Received October 14, 2014
Report
- Report Number
- 3006260740-2014-00517
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 19, 2014
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- PMA / PMN Number
- K830256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF HUXE1257 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THESE LOT NUMBERS.
Description of Event or Problem · 1
IT WAS REPORTED "THE LINE WAS NOT PATENT. A DECISION WAS MADE TO REMOVE THE CATHETER. THE CHILD WAS TAKEN INTO SURGERY. UPON REMOVAL, IT WAS NOTED THAT THE CATHETER APPEARED TO HAVE SPLIT IN TWO. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER 4.2 FRENCH BROVIAC CATHETER SUCCESSFULLY. THE PATIENT WAS UNHARMED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652557 | BROVIAC 4.2 FR SL CVC CUTDOWN TRAV WITH SURECUFF TISSUE IN | LJS | BARD ACCESS SYSTEMS | KUXE1257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |