FDA Adverse Event Injury Summary report: N

UNKNOWN BALLARD MINI-BAL SAMPLING CATHETER

MDR report key: 12143113 · Received July 9, 2021

Report

Report Number: 8030647-2021-00024
Event Type: Injury
Date Received: July 9, 2021
Report Date: July 9, 2021
Product Code: OYI
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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 · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1037513	UNKNOWN BALLARD MINI-BAL SAMPLING CATHETER	VAP AIRWAY DIAGNOSTICS BAL-CATH	OYI		UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening\| R