FDA Adverse Event
Malfunction
Summary report: N
SHARPS COLL 1.4L YELLOW TRAY SIZE
MDR report key: 11340721
·
Received February 17, 2021
Report
- Report Number
- 2243072-2021-00344
- Event Type
- Malfunction
- Date Received
- February 17, 2021
- Date of Event
- January 22, 2021
- Report Date
- February 8, 2021
- Manufacturer
- BECTON DICKINSON
- Product Code
- MMK
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ US (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT SHARPS COLL 1.4L YELLOW TRAY SIZE BREACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHARPS BREACH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236585 | SHARPS COLL 1.4L YELLOW TRAY SIZE | SHARPS CONTAINER | MMK | BECTON DICKINSON | 20275001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |