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Injection Needle IN12-255232302Recalls & reported problems

Micro-Tech (Nanjing) Co., Ltd. · POM inner tuber,Needle Length 5mm,with metal cap 25G*5*2.3*230,Shroat stucture · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06932503533249), received between Feb 27, 2024 and Sep 23, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Fell” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Fell1

Patient problems

  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2024Device Fell; Device Fell

    MICRO-TECH RECEIVED A MDR NOTIFICATION FROM FDA. MDR REPORT #: MW5152104. IT WAS REPORTED THAT INJECTION NEEDLE HAS A CLEAR TIP COVER THAT IS THE SAME COLOR AS THE TUBING AND EASILY FITS THROUGH THE SCOPE CHANNEL. THE USER INADVERTENTLY FORGOT TO REMOVE THE TIP COVER AND THE TIP CAME OFF IN THE PATIENTS COLON AND HAD TO BE RETRIEVED. THERE WAS NO INJURY TO PATIENT DUE TO THIS ERROR. RECOMMEND TIP COVER COLOR AND SIZE BE REVISED TO AVOID FUTURE INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20277425 ↗
  • OtherFeb 27, 2024

    INJECTION NEEDLE HAS A CLEAR TIP COVER THAT IS THE SAME COLOR AS THE TUBING AND EASILY FITS THROUGH THE SCOPE CHANNEL. THE USER INADVERTENTLY FORGOT TO REMOVE THE TIP COVER AND THE TIP CAME OFF IN THE PATIENTS COLON AND HAD TO BE RETRIEVED. THERE WAS NO INJURY TO PATIENT DUE TO THIS ERROR. RECOMMEND TIP COVER COLOR AND SIZE BE REVISED TO AVOID FUTURE INCIDENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 18799723 ↗

Other Endoscopic Injection Needle, Gastroenterology-Urology devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.