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AVANOS 40789Recalls & reported problems

Avanos Medical, Inc. · ON-Q* Pain Relief System T-bloc* Ultrasound Nerve Block Prep Tray · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494407896), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (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: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 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

  • Material Too Soft/Flexible1

Patient problems

  • Needle Stick/Puncture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 16, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

    IT WAS REPORTED, ¿OUR FELLOW HAD A NEEDLE STICK YESTERDAY.¿ PER ADDITIONAL INFORMATION RECEIVED ON 24SEP2024, ¿OUR TRAINEES EXPERIENCED A NEEDLE STICK WHILE USING OUR AVANOS CATHETER KIT FOR A NERVE BLOCK. WE HAVE REACHED OUT MULTIPLE TIMES REGARDING OUR CONCERN ABOUT THE FLIMSY NATURE OF THE FOAM IN THE CATHETER KIT - THE FACT THAT IT'S LOOSE IN THE KIT AND DOESN'T HAVE A HARD BACKING MEANS NEEDLES EASILY PUNCTURE THROUGH THE FOAM.¿ PER ADDITIONAL INFORMATION RECEIVED ON 25SEP2024, ¿PATIENT¿S HIV PANEL WAS INCONCLUSIVE. THE HEALTH CARE PROFESSIONAL (HCP) STARTED POST-EXPOSURE PROPHYLAXIS (PEP) FOR 1 WEEK WHILE WAITING FOR CONFORMATION TESTING TO BE COMPLETED.¿ THE FINGERSTICK OCCURRED AFTER PATIENT USE.

    Patient problems: Needle Stick/Puncture

    MAUDE report 20466832 ↗

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