MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP; INSTRUMENT, BIOPSY

Catalog Number	DJ4011X
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: five photos and one sample from lot number 0001600044 were provided to our quality team for investigation.During the visual inspection, no manufacturing defects were observed.However, a form of contamination or rust like appearance was noted on the needle tip inside the cannula.Based on the inspection performed, the reported failure mode, defective, could not be confirmed as a manufacturing issue, as no product related manufacturing defects were identified.Nonetheless, contamination or a rust like residue was observed on the tip of the received needle.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001600044 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Current manufacturing controls were evaluated.Work instruction was verified to include all required process steps for the proper assembly of the cannula, inner needle, housing threading, and cannula to retainer connection.The instruction includes all steps necessary to ensure correct product manufacturing.Likewise, it specifies the inspection of the needle fit (long or short) and the needle tip.These instructions include visual aids and inspection steps designed to detect issues related to improper assembly or any other abnormal condition.Based on the investigation performed and the information available at this time, a probable root cause could not be determined.No manufacturing defects were identified, and the source of the contamination or rust like residue observed on the needle tip remains unknown.It also remains undetermined whether any procedural deviations may have contributed to the reported event.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.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 by the customer that jamshidi bone marrow item was found to be defective when attempting to use it in the central processing room.This complaint is about tissue sampling failure before use.During the followup response, it was further reported that the affected product was not used, as the defect was noticed prior use on patient.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 24259552
• Report Number: 1423507-2026-00024
• Device Sequence Number: 9575009
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141(17)291101(10)0001600044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/02/2026

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: DJ4011X
• Device Lot Number: 0001600044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown