FDA Adverse Event
Malfunction
Summary report: N
TKMD
MDR report key: 12638781
·
Received October 15, 2021
Report
- Report Number
- 3017368639-2021-00175
- Event Type
- Malfunction
- Date Received
- October 15, 2021
- Date of Event
- September 22, 2021
- Report Date
- October 13, 2021
- Manufacturer
- ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD
- Product Code
- MEG
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
MCKESSON MEDICAL SURGICAL IS THE ASSEMBLER OF A CONVENIENCE KIT, ON BEHALF OF THE SNS, THAT INCLUDES THIS SAFETY SYRINGE. ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD MANUFACTURES THE SYRINGE THAT WAS INCLUDED IN THE KIT. (B)(4).
Description of Event or Problem · 0
THE CUSTOMER REPORTED THAT BOTH NURSES AND PATIENTS HAVE COMPLAINED THAT THE 1.5 NEEDLES RECEIVED IN THE KITS ARE CAUSING PAIN, ARE TOO BIG, AND ARE DIFFICULT TO ADMINISTER THE VACCINE WITH. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1541616 | TKMD | SAFEY SYRINGE WITH NEEDLE | MEG | ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD | 20201209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |