T-Lok™ Bone Marrow Biopsy Needle DBMNJ0804TLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886333001514), received between Apr 10, 2022 and Oct 17, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Failure to Obtain Sample; Failure to Obtain Sample

  WHEN CARRYING OUT AN OSTEOMEDULLARY BIOPSY ON (B)(6) 2023, FAILURE TO COLLECT THE MEDULLARY CORE BY THE EXTRACTION CANNULA WHICH IS NOT WATERPROOF AND DOES NOT ALLOW THE SAMPLE TO BE MAINTAINED TO RECOVER IT AT THE EXIT OF THE CANNULA. COLLECTION OF THE BIOPSY SAMPLE AFTER DIVERSION MANEUVER WHICH IS AT RISK OF HEMORRHAGE. THIS EVENT WAS A SOURCE OF STRESS FOR THE PATIENT AND CAUSED AN ORGANIZATIONAL DYSFUNCTION WITH AN EXTENSION OF THE DURATION OF HOSPITALIZATION OF THE PATIENT IN DAY HOSPITAL. TO COMPENSATE FOR THE INCIDENT, IT WAS NECESSARY TO APPLY SEVERAL PRESSURE DRESSINGS AND TO REINFORCE CLINICAL MONITORING.

  Patient problems: Discomfort; Distress

  MAUDE report 17950827 ↗
• MalfunctionFeb 21, 2023Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  THE PINCH ROD FROM THE BONE MARROW BIOPSY PACK BENT DURING THE PROCEDURE INSIDE PATIENT'S BODY. THE CLINICIAN NOTICED THIS WHEN THE NEEDLE ASSEMBLY WAS PULLED OUT AFTER THE PROCEDURE. THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410280 ↗
• MalfunctionSep 19, 2022Therapeutic or Diagnostic Output Failure

  "PRACTITIONER WAS PERFORMING BONE MARROW BIOPSY AS PER NORMAL. WHEN SHE PULLED OUT THE BIOPSY NEEDLE AND REMOVED THE CANNULA AND ATTEMPTED TO PUSH OUT CORE BIOPSY, THERE WAS A LONG PIECE OF METAL THAT CAME OUT. NO BIOPSY SPECIMEN PRESENT. APPEARS THAT IT CAME FROM INSIDE THE NEEDLE ITSELF. SHE PERFORMED THE PROCEDURE WITH ANOTHER NEEDLE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445833 ↗
• MalfunctionAug 9, 2022Product Quality Problem; Inadequacy of Device Shape and/or Size

  THE ACCESS DEVICE DOES NOT ALLOW FOR THE TRAP PIECE TO BE INSERTED WITH EASE (RESISTANCE CAN BE FELT) AND IT CREATES A MORE NARROW END AT THE POINT WHERE THE CORE BIOPSY SAMPLE WOULD BE OBTAINED. BECAUSE OF THIS, THE CORE SAMPLE HAS NOT BEEN AS LONG/ADEQUATE AS NORMAL AND THE NURSES ARE HAVING TO INSERT THE TRAP MULTIPLE TIMES TO GET ENOUGH OF A SAMPLE. THE NEEDLE IS SMALLER IN THIS LOT THAN WHAT IT SHOULD BE, IT TAKES MULTIPLE PASSES TO GET WHAT IS NEEDED. THE NEEDLE IS SMALLER IN THIS LOT THAN WHAT IT SHOULD BE, IT TAKES MULTIPLE PASSES TO GET WHAT IS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 15190903 ↗
• MalfunctionApr 21, 2022Product Quality Problem

  HEMATOLOGIST DR. (B)(6) CALLED ME YESTERDAY REGARDING POORER QUALITY OF THE BONE MARROW NEEDLES OVER LONGER TIME. HE HAS BEEN USING OUR NEEDLES FOR AT LEAST 15 YEARS, AND ONLY US, 150-200 NEEDLES PER YEAR.(DBMNJ0806 MOSTLY). IN A NATIONAL STUDY A WHILE AGO, ÅLESUND RECEIVED THE HIGHEST SCORE ON BIOPSY QUALITY. THEY MEASURED LENGTH THICKNESS, AND THE PATHOLOGIST'S DESCRIPTION AMONG OTHER THINGS. NOW THEY MUST USE MORE FORCE TO GET THROUGH THE MARROW. UNISON FROM 5 DOCTORS, INCLUDING HIMSELF. A FEMALE DOCTOR IS NO LONGER ABLE TO TAKE BIOPSIES DUE TO LACK OF POWER. SHE BLAMES HER AGE A BIT, BUT THAT CAN´T BE THE EXPLANATION. 2. THE PATHOLOGISTS DESCRIBE THE BIOPSY AS MORE COMPRESSED THAN BEFORE. THIS CAUSES FRACTURES IN THE MATERIAL AND THE DIAGNOSIS IS MADE MORE DIFFICULT. APRIL 21TH; HE WILL COMPARE TODAY NEEDLES WITH OLDER NEEDLES PRODUCED IN 2018 AND 2019 WE HOPE TO GET CLOSER TO THE PROBLEM IN THIS WAY. I WILL RETURN SOME NEEDLE AND SOME OLD NEEDLE TO COMPARE AFTER THE MEETING APRIL21.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165153 ↗
• InjuryApr 10, 2022Material Deformation; Material Twisted/Bent

  BONE MARROW NEEDLE CANT HANDLE PRESSURE NECESSARY TO PENETRATE BONE, KINKS AND BENDS SLIPS AWAY FROM PENETRATION SITE DOES NOT CUT SAMPLE PROPERTY AND SHATTERS THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14069283 ↗