TKMD TKSN (UDI 06934841570047)Recalls & reported problems
Anhui Tiankang Medical Technology Co., Ltd. · The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06934841570047), received between Jun 15, 2021 and Aug 3, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Retraction Problem2
- Unintended Movement2
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- Needle Stick/Puncture3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2023Retraction Problem; Unintended Movement; Retraction Problem; Unintended Movement
COMPLAINANT REPORTED MULTIPLE NEEDLESTICK EVENTS WHERE THE SAFETY SHIELDS ON THE BLUE 23GX1.5" NEEDLE EITHER BECOMES OFF CENTER AND DOES NOT LOCK OR COVER THE NEEDLE. ADDITIONALLY, THE NEEDLE SHIELD CAN BE PUSHED BACK OPEN EVEN AFTER IT HAS BEEN LOCKED.
Patient problems: Needle Stick/Puncture
MAUDE report 17455197 ↗MalfunctionAug 3, 2023Retraction Problem; Unintended Movement; Retraction Problem; Unintended Movement
COMPLAINANT REPORTED MULTIPLE NEEDLESTICK EVENTS WHERE THE SAFETY SHIELDS ON THE BLUE 23GX1.5" NEEDLE EITHER BECOMES OFF CENTER AND DOES NOT LOCK OR COVER THE NEEDLE. ADDITIONALLY, THE NEEDLE SHIELD CAN BE PUSHED BACK OPEN EVEN AFTER IT HAS BEEN LOCKED.
Patient problems: Needle Stick/Puncture
MAUDE report 17455196 ↗MalfunctionJun 15, 2021Product Quality Problem; Material Twisted/Bent
[TKMD SAFETY NEEDLE] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): NEEDLE BENDS CONSIDERABLY WHEN INSERTING INTO THE SAFETY DEVICE AND CAN SNAP BEFORE CLICKING. MORE NEEDLE STICKS HAVE OCCURRED USING THESE NEEDLES THAN EVER PREVIOUSLY IN OUR ORGANIZATION SO WE HAVE GREAT CAUSE FOR CONCERN AND WOULD LIKE THE ISSUE TO BE STUDIED FURTHER. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Needle Stick/Puncture
MAUDE report 12007979 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page