STATLOCK ARTERIAL CATHETER RETAINER
Received Apr 15, 2021 · Event occurred Mar 4, 2021
Report 3006260740-2021-01345 · MDR key 11675585
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
79 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem
IT WAS REPORTED VIA FDA AIR LETTER "THE ARTERIAL LINE TUBING DISCONNECTED COMPLETELY FROM THE CATHETER AND THE PATIENT LOST BLOOD, REQUIRING LAB DRAW TO ASSESS. POTENTIAL FOR HARM." ADD INFO RCVD 04/01/2021: PLACEMENT INFO: THE ARTERIAL LINE WAS PLACED IN THE OPERATING ROOM, IN THE PATIENTS RIGHT RADIAL ARTERY A DETAILED DESCRIPTION OF THE EVENT: THE ARTERIAL LINE TUBING DISCONNECTED COMPLETELY FROM THE CATHETER ON (B)(6) 2021, CAUSING THE PATIENT TO LOSE A LARGE AMOUNT OF BLOOD. WAS THERE PATIENT HARM REPORTED?: NO.