MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; TRAY,BONE MARROW,W/DISP 4" NEEDLE

Catalog Number	DYNJTS0214
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility.The needle, 11g, 4.000" broke apart in a patient while performing a bone marrow collection.The provider had to find and use forceps to remove the needle.There was no further information.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility.The needle, 11g, 4.000" broke apart in a patient while performing a bone marrow collection.The provider had to find and use forceps to remove the needle.

• Common Device Name: TRAY,BONE MARROW,W/DISP 4" NEEDLE
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico; s. de r.l. de c.v; mexicali, baja california 21397 ,; MX 21397,
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21313120
• Report Number: 3004519921-2025-00003
• Device Sequence Number: 8076237
• Product Code: LRO
• UDI-Device Identifier: 10653160375937
• UDI-Public: 10653160375937
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: DYNJTS0214
• Device Lot Number: 2024092690
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown