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 |