NA OTP5000KRecalls & reported problems
Carefusion 2200, Inc · Thora-Para 5 Fr Non-Valved Catheter Drainage Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10885403284755), received between May 25, 2022 and May 25, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Handling Problem1
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.
InjuryMay 25, 2022Device Handling Problem; Device Handling Problem
IT WAS REPORTED BY CUSTOMER THAT DR. WAS LOOKING AT OUR DISPOSABLE SCALPEL AND CUT HIS HAND. VERBATIM: I WASN'T AWARE I SHOULD REPORT THAT AT THE TIME. MY MISTAKE. DURING A PRODUCT DEMONSTRATION DR WAS LOOKING AT OUR DISPOSABLE SCALPEL AND CUT HIS HAND. HE DIDN'T CARE, AND BLAMED HIMSELF. IT WAS A TINY POKE. DR CUT HIS HAND WITH OUR DISPOSABLE SCALPEL IN OTP5000K KIT. DR WAS SAYING HOW HE LIKED THE NEW SCALPEL BETTER THAN THE OLDER ONE AND PROCEEDED TO OPEN IT IN THE WRONG DIRECTION INTO HIS HAND. A VERY SMALL POKE ENOUGH TO MAKE HIM JUMP.
Patient problems: Needle Stick/Puncture
MAUDE report 14496400 ↗
Other Thoracentesis tray devices
- Safe-T-Centesis PIG1260TCarefusion 2200, Inc · Thoracentesis tray2 recalls27 reports
- Safe-T-Centesis PIG1260KCarefusion 2200, Inc · Thoracentesis tray1 recall73 reports
- NA OTP5000Carefusion 2200, Inc · Thoracentesis tray2 recalls13 reports
- Safe-T-Centesis PIG1280KCarefusion 2200, Inc · Thoracentesis tray108 reports
- NA TPT1000Carefusion 2200, Inc · Thoracentesis tray1 recall1 death19 reports
- Safe-T-Centesis PIG1280TCarefusion 2200, Inc · Thoracentesis tray1 recall8 reports
- Safe-T TPT1000SPCarefusion 2200, Inc · Thoracentesis tray1 recall6 reports
- NA TPT1005Carefusion 2200, Inc · Thoracentesis tray1 recall1 report
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.
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