MAUDE Adverse Event Report: CARDINAL HEALTH BN MAR BIOP/ASP NDL 11X4LL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	8881247111
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the mesc collection procedure, the aspirate needle was inserted by the operator at the level of the right posterior iliac crest, in order to proceed with bone marrow blood aspiration.Subsequently, when the operator was withdrawing the needle, the handle of the device disengaged from the needle and remained stuck in the thickness of the bone.In a few minutes, using klemmer forceps, it was possible to remove the needle from the bone seat, and continue with the collection procedure using other needles from the same batch, without further incidents.There was no patient injury reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Updated h6 evaluation codes: health effect - clinical code to code 2687.
Additional Manufacturer Narrative
A sample was not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: BN MAR BIOP/ASP NDL 11X4LL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16545790
• Report Number: 1282497-2023-10746
• Device Sequence Number: 5946450
• Product Code: GAA
• UDI-Device Identifier: 10884521020498
• UDI-Public: 10884521020498
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2023

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
• Device Model Number: 8881247111
• Device Catalogue Number: 8881247111
• Device Lot Number: 190880224
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 02/24/2023; 02/24/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 03/20/2023; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown