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

Lot Number	2220327
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Upon receipt of the medwatch a complaint number was assigned, notheless, the descriptions noted in the required further clarification and the reported was contacted at the email noted in the medwatch with the following questions: 1.There are two needles used for bone marrow biopsy in the kit.Can you please clarify whether you are referring to: a.I - style.B.J - style.C.Both.Since there had been no response by (b)(6) 2022 the reported was contacted by phone.There was no response but a voicemail was left, refering the email sent and an email was also sent after the voicemail to document contact.After this, three more emails were sent, with no response from the reporter.Communications were as followed: 1.Email - (b)(6) 2022, 2.Voicemail - (b)(6) 2022, 3.Email - (b)(6) 2022, 4.Email - (b)(6) 2022, 5.Email - (b)(6) 2022.Nonetheless, eventhough the reported was not clarified, we moved on to inspect stock of both types of needles included in the kit.Although the controls used were no longer available, the current stock was reviewed and passed all established requirements.Furthermore, review of the device history record proved the ifu was included with the product, as first and last pieces were part of the documents.In, regards to the "guard" we were not sure what this was in reference to, and it was not clarified by reporter.Therefore, no further investigation could be conducted and review of complaints did not reveals any trends for the issue and/or parts, corrective and preventive actions were not deemed necessary.

• Brand Name: BUSSE HOSPITAL DISPOSABLES
• Common Device Name: BONE MARROW BIOPSY/ASPIRATION TRAY W/ BIOPSY NEEDLES & ASPIRATION
• Manufacturer (Section D): BUSSE HOSPITAL DISPOSABLES; 75 arkay drive; hauppauge NY 11788
• Manufacturer Contact: muhamad ansari ; 75 arkay drive; hauppauge, NY 11788 ; 6314354711
• MDR Report Key: 15641034
• Report Number: 2433012-2022-00003
• Device Sequence Number: 5715402
• Product Code: KNW
• UDI-Device Identifier: 10849233013275
• UDI-Public: 0110849233013275
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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: 01/30/2023
• Device Lot Number: 2220327
• 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: 09/29/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown