MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE; Instrument, Biopsy

Catalog Number	EJM4011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction

• Brand Name: JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE
• 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: michael gaffney ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 25876584
• Report Number: 1423507-2026-00104
• Device Sequence Number: 20833398
• Product Code: KNW
• UDI-Device Identifier: 10885403464157
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: EJM4011
• Device Lot Number: 0001649609
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown