MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP; INSTRUMENT, BIOPSY

Catalog Number	BAK4511
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11.No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history record could not be evaluated as the lot number is unknown.Based on the available information we are not able to identify a root cause at this time.The complaint has been logged in the complaint management system and will be monitored through tracking, trending, and quality data analysis for potential future occurrences.D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown b3 (date of event: date of awareness was entered in the date of event field as the actual date of event is unknown).G4: pma/510k : k171531;k813338.D2: procode: fsh;knw.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
The customer reported that certain components within the jamshidi bone marrow tray 11g x 4, 15g asp were found to be dusty or dirty.

• Brand Name: JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 24580073
• Report Number: 1423507-2026-00041
• Device Sequence Number: 9435029
• Product Code: KNW
• UDI-Device Identifier: 10885403057236
• UDI-Public: (01)10885403057236
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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 Catalogue Number: BAK4511
• Device Lot Number: UNKNOWN
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown