FDA Adverse Event Malfunction Summary report: N

SUCTION CANISTER

MDR report key: 16700850 · Received April 7, 2023

Report

Report Number
16700850
Event Type
Malfunction
Date Received
April 7, 2023
Date of Event
March 27, 2023
Report Date
March 28, 2023
Manufacturer
CARDINAL HEALTH 200, LLC
Product Code
KDQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CT
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

[REDACTED NAME] NOTED THAT THE SUCTION CANNISTERS DO NOT FIT WELL. THE LID IS MISFITTING AND NOTED THAT THEY POP OFF WHEN PATIENTS ARE ON SUCTION AND ARE NOT CREATING ENOUGH SUCTION AT TIMES. MANUFACTURER RESPONSE FOR SUCTION CANISTER, SUCTION CANISTER (PER SITE REPORTER) MANUFACTURER NOTIFIED, AND THEY ARE RETRIEVING A SAMPLE ON [REDACTED DATE] FOR INSPECTION. LOT# IN THE WAREHOUSE IS GOOD ITS J211-602.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1754510 SUCTION CANISTER BOTTLE, COLLECTION, VACUUM KDQ CARDINAL HEALTH 200, LLC

Patients

Seq Age Sex Outcome Treatment
1 Unknown