FDA Adverse Event
Malfunction
Summary report: N
TKMD
MDR report key: 16156877
·
Received January 13, 2023
Report
- Report Number
- 3017368639-2022-00035
- Event Type
- Malfunction
- Date Received
- January 13, 2023
- Date of Event
- December 14, 2022
- Report Date
- January 8, 2023
- Manufacturer
- ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
- Product Code
- FMI
- UDI-DI
- 06934841570016
- PMA / PMN Number
- K191644
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT CAN CONTAIN THE DEVICE FROM THE MANUFACTURER IDENTIFIED IN SECTION D. THE ITEM REF # AND LOT # REPORTED AND IDENTIFIED IN SECTION D HAVE BEEN CONFIRMED AS HAVING BEEN USED IN THE ASSEMBLY OF CONVENIENCE KITS SUPPLIED BY MCKESSON MEDICAL-SURGICAL, INC. WE HAVE NOTIFIED [email protected] AND [email protected] FOR AWARENESS.
Description of Event or Problem · 0
CUSTOMER REPORTED THAT, ON THREE SEPARATE OCCASIONS, TKMD NEEDLES FAILED TO ENGAGE WITH THE SAFETY SHEATH AFTER ADMINISTRATION. THE CUSTOMER INDICATED THAT THE SAFETY FEATURE BROKE OFF BEFORE THE NEEDLE ENCASED CORRECTLY, AND THE NEEDLE POKED THROUGH THE SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1224805 | TKMD | TKMD SAFETY NEEDLE | FMI | ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. | TKSN-006 | 20210405 | 06934841570016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |