FDA Adverse Event
Summary report: N
HYPODERMIC NEEDLE
MDR report key: 16077329
·
Received December 29, 2022
Report
- Report Number
- MW5114079
- Date Received
- December 29, 2022
- Report Date
- December 29, 2022
- Manufacturer
- CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
- Product Code
- FMI
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
COVID VACCINE ADMINISTRATION KITS PROVIDED BY CDC HAVE A VARIETY OF ISSUES DURING PREPARATION AND ADMINISTRATION OF VACCINE: SMITH'S MEDICAL HYPODERMIC NEEDLE-PRO AND CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD: THESE NEEDLES HAVE A PROTECTION DEVICE, BUT THE NEEDLE CAN SEPARATE FROM THE DEVICE. YANGZHOU MEDLINE INDUSTRY CO. DISPOSALE SYRINGE WITHOUT NEEDLE (LUER LOCK TIP) AND MEDLINE INDUSTRIES INC. LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE - MEASUREMENTS PRINTED UPSIDE DOWN AT TIMES, SCREW-TOP CONNECTION SLIDING OFF OF NEEDLE, NOT CONNECTING AND VACCINE LEAKING. SUBMISSION ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471272 | HYPODERMIC NEEDLE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD. | |||
| 471273 | DISPOSABLE SYRINGE | SYRINGE, PISTON | FMI | YANGZHOU MEDLINE INDUSTRY CO., LTD. | |||
| 471274 | DISPOSABLE SYRINGE | SYRINGE, PISTON | FMI | MEDLINE INDUSTRIES, LP - NORTHFIELD | |||
| 471275 | HYPODERMIC NEEDLE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | SMITHS MEDICAL ASD, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |