MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI EVOLVE; INSTRUMENT, BIOPSY

Catalog Number	EJM4011
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.The physical sample has not been returned.A photo was provided; a photo review is underway.Upon completion of the investigation, a supplemental report will be filed.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
It was reported that on (b)(6) 2025, the jamshidi needle had a package issue as there was blue color showing inside the package.The issue was reported to be detected during installation; however, it was also reported that the affected product was not used on a patient.Furthermore, there was no impact to the patient reported.
Additional Manufacturer Narrative
H11: a physical sample was not received by our quality team for evaluation.One photograph was provided by the customer and reviewed.During photo review, the image showed the presence of blue particulate.Therefore, the investigation was confirmed for the reported failure.However, since a physical sample was not evaluated, a definitive determination regarding the source of the particulate cannot be made.As a result, the root cause could not be confirmed and is unknown.The suppliers responsible for the stylet handle, cannula retainer, handle subassembly, and depth stop have been notified of this occurrence.Additionally, awareness training was conducted with the packaging team to increase awareness.A review of the device history record (dhr) for part: ejm4011 lot: 0001589121 was conducted.No confirmed quality issues or rejections related to the reported incident were identified.The review verified that all procedural and functional criteria required for product release were fully satisfied.The complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis process.B5 (describe event or problem), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h6: annex g (component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).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
It was reported that on 16-october-2025, the jamshidi needle had a package issue as there was blue color showing inside the package.The issue was reported to be detected during installation; however, it was also reported that the affected product was not used on a patient.Furthermore, there was no impact to the patient reported.Based on follow up response, it was further confirmed that there was no patient harm and that the issue was identified when the packaged was being opened.The doctor returned to the purchase department prior to being used.

• Brand Name: JAMSHIDI EVOLVE
• 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: 23533003
• Report Number: 1423507-2025-00144
• Device Sequence Number: 10186605
• Product Code: KNW
• UDI-Device Identifier: 10885403464157
• UDI-Public: (01)10885403464157(17)290831(10)0001589121
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 0001589121
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown