Jamshidi BCTM3411SPRecalls & reported problems
Carefusion 2200, Inc · JAMSHIDI (TJ) SAFE-T PLUS BM TRAY 11GMAC · Class 2
All models of Jamshidi (18)
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 10885403107702), received between Nov 13, 2023 and Nov 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Component” (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.
Reports received per month
Most reported problems
Device problems
- Defective Component1
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.
InjuryNov 13, 2023Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER THAT SEVERAL PHYSICIAN COMPLAINS OF DULL SCALPEL, POOR SAFETY CAP ON SCALPEL. PA WAS DOING A BONE MARROW BIOPSY ON A PATIENT AND WAS FINISHED USING THE SCALPEL- SAFETY CAP FAILED AND CUT PA WITH DIRTY SCALPEL. PA WAS SENT TO ED FOR BLOOD EXPOSURE AND EXPOSURE PACKET COMPLETED. THIS BONE MARROW TRAY ALSO DOES NOT HAVE A SHARPS PAD TO USE WHEN DONE WITH THE SHARPS. VERBATIM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SEVERAL PHYSICIAN COMPLAINS OF DULL SCALPEL, POOR SAFETY CAP ON SCALPEL. PA WAS DOING A BONE MARROW BIOPSY ON A PATIENT AND WAS FINISHED USING THE SCALPEL- SAFETY CAP FAILED AND CUT PA WITH DIRTY SCALPEL. PA WAS SENT TO ED FOR BLOOD EXPOSURE AND EXPOSURE PACKET COMPLETED. THIS BONE MARROW TRAY ALSO DOES NOT HAVE A SHARPS PAD TO USE WHEN DONE WITH THE SHARPS.
Patient problems: Needle Stick/Puncture
MAUDE report 18122547 ↗
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- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 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.
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