TRAPSYSTEM SETRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08033003347881), received between Feb 2, 2018 and Oct 29, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  TRAPSYSTEM NEEDLE HANDLE BROKE OFF WHILE BEING INSERTED DURING BONE MARROW BIOPSY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8014147 ↗
• MalfunctionApr 24, 2018Pressure Problem; Pressure Problem

  DURING THE BONE MARROW PROCEDURE THE JAMSHIDI NEEDLE HAD A PROBLEM DURING THE ASPIRATION (LACK OF DEPRESSION, 3 NEEDLES WERE DEFECTIVE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453844 ↗
• MalfunctionMar 20, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING THE BONE MARROW PROCEDURE THE JAMSHIDI NEEDLE BENT OR BROKE AND WAS UNABLE TO BE USED (3 NEEDLES USED IN (B)(6) 2018).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352372 ↗
• MalfunctionFeb 6, 2018Break

  JAMSHIDI NEEDLE BROKE WHILE NURSE PRACTITIONER PERFORMING BONE MARROW BIOPSY. REQUIRED REPEAT OF THE PROCEDURE ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7243622 ↗
• MalfunctionFeb 6, 2018Break

  JAMSHIDI NEEDLE BROKE DURING BIOPSY. SECOND DEVICE TO BREAK THIS MONTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7243615 ↗
• MalfunctionFeb 6, 2018Bent

  DURING THE BONE MARROW PROCEDURE, THE (B)(6) NEEDLE BENT AND WAS UNABLE TO BE USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7243593 ↗
• MalfunctionFeb 2, 2018Break; Detachment Of Device Component; Difficult to Remove

  AS REPORTED IN MW5072812: BONE MARROW BIOPSY SET. 2 SET BROKE DURING THE PROCEDURE CAUSING THE VETERAN TO HAVE TO BE STUCK THREE TIMES IN ORDER TO GET THE BIOPSY. THE SET BROKE AT HANDLE LEAVING A LARGE NEEDLE STUCK IN VETERAN THAT WAS DIFFICULT TO REMOVE. SA 2/2 OTHER-EQUIPMENT ISSUE- MODERATE HARM TO PATIENT. BONE MARROW BIOPSY PROCEDURE TO BE REPEATED BY IR. PATIENT UNDERWENT 3 NEEDLE ATTEMPTS WITH ONE ATTEMPT RESULTING IN HANDLE BREAKING CAUSING NEEDLE TO STAY IN PATIENT WITHOUT HANDLE TO EASILY REMOVE. TWO BONE MARROW BIOPSY KITS BROKE AT POINT OF HANDLE LEAVING A LARGE NEEDLE STUCK IN PATIENT THAT WAS DIFFICULT TO REMOVE. BIOPSY COMPLETED AND ANOTHER BONE MARROW PROCEDURE TO BE REPEATED BY IR.

  Patient problems: Foreign Body In Patient

  MAUDE report 7237004 ↗