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

Catalog Number	DJ4011X
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: a lot number was provided; the device history records are currently under review.The investigation is currently underway.H3 (device eval by manufacturer) a device has not been returned.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 by customer that on (b)(6) 2025, when the jamshidi was inserted, needle there was some leakage so not able to aspirate.No patient harm was reported.The clinician used another jamshedi needle to complete the procedure.
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 review of the internal manufacturing device records and raw material history files for the reported lot number 0001608297 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.A probable root cause for this reported failure mode could not be established since it was not provided enough information to fully investigate this incident.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.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 by customer that on (b)(6) 2025, when the jamshidi was inserted, needle there was some leakage so not able to aspirate.No patient harm was reported.The clinician used another jamshedi needle to complete the procedure.

• 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: 23622653
• Report Number: 1423507-2025-00151
• Device Sequence Number: 8978069
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141(17)300105(10)0001608297
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 0001608297
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown