MAUDE Adverse Event Report: BUSSE HOSPITAL DISPOSABLES; BONE MARROW BIOPSY / ASPIRATION TRAY W/ BIOPSY & ASPIRATION NEEDLE / STERILE / L

Catalog Number	652
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was initiated following receipt of a complaint regarding a bent needle observed during a bone marrow biopsy.The reporter confirmed the needle appeared normal during insertion, with resistance only noticed upon removal.The procedure was performed in accordance with the product's instructions for use, and no unusual patient anatomy or positioning was reported.No additional medical intervention was necessary, and the incident was described as isolated by the facility.Although an image of the needle was submitted, the physical sample was not returned despite multiple follow-up attempts.The user confirmed that a bone marrow sample was successfully obtained during the procedure.A comprehensive review of manufacturing and quality control records, along with a re-inspection of current inventory, revealed no deviations or issues.Notably, the report referenced an i-style needle, while the image showed a j-style needle.A previous complaint from the same facility involved a similar issue with a j-style needle, where improper technique was suspected.It was also noted that the product was used beyond its expiration date.Based on image review and contextual information, the observed bending could be consistent with factors such as repositioning during removal, advancement without the trocar, or improper insertion technique.
Event or Problem Description
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.

• Common Device Name: BONE MARROW BIOPSY / ASPIRATION TRAY W/ BIOPSY & ASPIRATION NEEDLE / STERILE / L
• Manufacturer (Section D): BUSSE HOSPITAL DISPOSABLES; 75 arkay drive; hauppauge 11788
• Manufacturer (Section G): BUSSE HOSPITAL DISPOSABLES; 75 arkay drive; hauppauge NY 11788
• Manufacturer Contact: muhamad ansari ; 75 arkay drive; hauppauge, NY 11788 ; 8006456526
• MDR Report Key: 22052711
• Report Number: 2433012-2025-00002
• Device Sequence Number: 5355390
• Product Code: PRV
• UDI-Device Identifier: 00849233013278
• UDI-Public: 00849233013278
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 652
• Device Lot Number: 2220860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown