MAUDE Adverse Event Report: CENTURION; BIOPSY TRAY

Catalog Number	DYNDH1137D
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on (b)(6), "i performed a bone marrow.The procedure went smoothly, patient's bone consistency was felt to be normal, neither hard nor soft and bone collection/extraction was without difficulty.Bone biopsy was collected as per our routine procedure, using the hourglass and light pressure with the jamshidi guide, a 1.4 cm bone biopsy was collected and upon inspection a metallic shiny object was present at the end of the biopsied sample.".
Additional Manufacturer Narrative
According to the customer on (b)(6), "i performed a bone marrow.The procedure went smoothly, patient's bone consistency was felt to be normal, neither hard nor soft and bone collection/extraction was without difficulty.Bone biopsy was collected as per our routine procedure, using the hourglass and light pressure with the jamshidi guide, a 1.4 cm bone biopsy was collected and upon inspection a metallic shiny object was present at the end of the biopsied sample.I asked my ma/assistant to take a picture of this sample, separate the object and preserve it between slides.I inspected the jamshidi and could not identify additional objects or defects.I was able to finish the procedure without complications".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.

• Common Device Name: BIOPSY TRAY
• Manufacturer (Section D): CENTURION; 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: 19520887
• Report Number: 3004519921-2024-00030
• Device Sequence Number: 20376138
• Product Code: LRP
• UDI-Device Identifier: 00653160361186
• UDI-Public: 00653160361186
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/12/2024

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 Catalogue Number: DYNDH1137D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/12/2024
• 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