FDA Adverse Event
Malfunction
Summary report: N
CATHETER SUCT PH W/O CONT 10FR STRT PK
MDR report key: 13956879
·
Received March 30, 2022
Report
- Report Number
- 8030673-2022-00237
- Event Type
- Malfunction
- Date Received
- March 30, 2022
- Date of Event
- February 28, 2022
- Report Date
- March 2, 2022
- Manufacturer
- VYAIRE MEDICAL
- Product Code
- BSY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
VYAIRE MEDICAL IDENTIFICATION: (B)(4). THE CUSTOMER DID NOT SEND THE PHYSICAL SAMPLE OR PICTURES FOR INVESTIGATION SO THE REPORTED DEFECT WAS NOT CONFIRMED. THE DEVICE RECORD HISTORY FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES WERE FOUND. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED TO VYAIRE MEDICAL THAT SUCTION CATHETER HUB BROKE OFF IN THE MIDDLE OF THE PROCEDURE. THE CUSTOMER CONFIRMED THAT NO HARM WAS DONE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2029352 | CATHETER SUCT PH W/O CONT 10FR STRT PK | SUCTION CATHETER KITS | BSY | VYAIRE MEDICAL | CATHETER SUCT PH W/O CONT 10FR STRT PK | 0004190568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |