UNKNOWN BALLARD MINI-BAL SAMPLING CATHETER
Received Jul 9, 2021
Report 8030647-2021-00024 · MDR key 12143113
Device
Product problems
- Malposition of Device
- Malposition of Device
Patient
Not reported
- Pneumothorax
- Respiratory Insufficiency
- Pneumothorax
- Respiratory Insufficiency
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 08 JUL 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).
Description of Event or Problem
IT WAS REPORTED THE CATHETER WAS USED IN A SERIOUSLY ILL COVID PATIENT. THE PATIENT HAD A PNEUMOTHORAX; EXACT DATE OF EVENT IS UNKNOWN. IT'S UNKNOWN WHETHER THE CATHETER WAS THE CAUSE OF THE PNEUMOTHORAX. A DRAIN WAS PLACED. THE PATIENT DETERIORATED AND HAD TO BE RESUSCITATED; CPR WAS SUCCESSFUL. THE PATIENT PASSED AWAY 2 TO 3 WEEKS LATER AS A RESULT OF THE COVID INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.