FDA Adverse Event
Malfunction
Summary report: N
PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 CM)
MDR report key: 4173526
·
Received October 10, 2014
Report
- Report Number
- 3006260740-2014-00512
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- August 22, 2014
- Report Date
- September 19, 2014
- Manufacturer
- BARD ACCESS SYSTEMS INC.
- Product Code
- LJS
- PMA / PMN Number
- K954104
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A LOT HISTORY REVIEW (LHR) OF REYA1327 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REYA1327) HAVE BEEN REPORTED FROM ONE MEXICO FACILITY. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED.
Description of Event or Problem · 1
DURING THE INSTALLATION PROCESS OF CATHETER IN PATIENT BY DOCTOR, IT WAS OBSERVED THAT THE CATHETER EASILY DETACHED FROM THE "BUTTERFLY" (SUTURE WINGS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642745 | PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) (30 CM) | LJS | BARD ACCESS SYSTEMS INC. | REYA1327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |