Busse Hospital Disposables 652Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849233013278), received between Sep 15, 2022 and May 20, 2025 — classified as 4 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON 04/29/2025 THE FDA FORWARDED REPORT, MW5169163, WHICH WAS SUBMITTED TO THEM TROUGH FDA'S MEDWATCH PROGRAM. UPON REVIEW, THE SUBMISSION WAS MADE FOR BUSSE ITEM 652, LOT#2220860. THE REPORTED NOTED "WHEN THE PROVIDER WAS REMOVING THE BONE MARROW NEEDLE FROM THE PATIENT'S BODY IT HAD A SLIGHT BEND TO IT." IMMEDIATELY, A COMPLAINT INVESTIGATION WAS OPENED, AND REPORTER NOTED IN THE REPORT WAS CONTACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052711 ↗
• MalfunctionOct 20, 2022Product Quality Problem; Product Quality Problem

  ON (B)(6) 2022 THE FDA FORWARDED BUSSE HOSPITAL DISPOSABLES A VOLUNTARY MEDWATCH REPORT WHICH HAD BEEN SUBMITTED UNDER UF/IMPORTER REPORT# 4900240000-2022-8092, DATING THE EVENT ON (B)(6) 2022 AND SUBMITTED BY CLINICAL ADVANCEMENT AND PATIENTY SAFETY, REPORTED: (B)(6). THE DESCRIPTION OF THE REPORT READS AS FOLLOWED: "MARROW STUCK INSIDE NEEDLE, NOT USER FRIENDLY, NO DIRECTIONS INSIDE PACKAGING, GUARD DOESN'T WORK, DEVICE IS VERY DIFFICULT TO USE, DOES NOT FIT IN A NORMAL SHARPS BOX THA IS INSIDE OF PATIENT ROOMS. IMMEDIATLY UPON RECEIPT, BUSSE OPENED A COMPLAINT, INVESTIGATED, INSPECTED, REVIEWED/DOCUMENTED, AND CONTACTED THE NOTED REPORTER IN THE MEDWATCH TO REQUEST CLARIFICATION ON THE SUBMISSION. ALTER MULTIPLE ATTEMPS TO CONTACT THE REPORTER THROUGH BOTH PHONE AND EMAIL, THERE HAS BEEN NO RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15641034 ↗
• MalfunctionSep 29, 2022Entrapment of Device; Inadequacy of Device Shape and/or Size; Use of Device Problem; Defective Component; Missing Information

  MARROW STUCK INSIDE NEEDLE, NOT USER FRIENDLY, NO DIRECTIONS INSIDE PACKAGING, GUARD DOESN'T WORK, DEVICE IS VERY DIFFICULT TO USE, DOES NOT FIT IN A NORMAL SHARPS BOX THAT IS INSIDE OF PATIENT ROOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502876 ↗
• MalfunctionSep 15, 2022Mechanical Problem; Mechanical Problem

  ON 08/19/2022 BUSSE HOSPITAL DISPOSABLES RECEIVED NOTIFICATION FROM THE FDA FOR A VOLUNTARY MEDWATCH REPORT WHICH HAS BEEN SUBMITTED UNDER MW5111258 FOR A PRODUCT WE MARKET. THE DESCRIPTION OF THE EVENT/PROBLEM UNDER THE SUBMISSION READS AS FOLLOWED: "PHYSICIAN WAS UNABLE TO GET A SAMPLE WITH 3 PASSES USING THE NEEDLE BECAUSE IT KEPT BENDING AS HE TRIED TO GET THE SAMPLE OUT. FDA SAFETY REPORT ID# (B)(4)".

  Patient problems: Discomfort

  MAUDE report 15430365 ↗