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

Catalog Number	EJM4011
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
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.A photo was provided for review; photo review is pending.The device has been returned and is pending evaluation.The investigation is currently underway.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 inner stylet disengaged from the handle causing it to get stuck and they had to use a forceps to remove the inner stylet resulting in prolonged procedure, specimen not collected appropriately.A new needle had to be used.Based on follow up response received on 30-jan-2026 it was further reported that the issue occurred during advancing the device inside the patient during the bone marrow biopsy procedure, as a result only partial specimen was collected.The partial sample was sent for analysis.No patient harm was reported.
Event or Problem Description
It was reported that on (b)(6) 2025.The jamshidi needle inner stylet disengaged from the handle causing it to get stuck and they had to use a forceps to remove the inner stylet resulting in prolonged procedure, specimen not collected appropriately.A new needle had to be used.Based on follow up response received on 30-jan-2026 it was further reported that the issue occurred during advancing the device inside the patient during the bone marrow biopsy procedure, as a result only partial specimen was collected.The partial sample was sent for analysis.No patient harm was reported.
Additional Manufacturer Narrative
H11: one jamshidi needle was received and evaluated.During evaluation, the cannula and stylet handles were not loose; no issues were observed.The failure was unable to be recreated.A definite root cause could not be determined.A review of the device history record (dhr) for part: ejm4011 lot: 0001628990 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 was entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis process.G3 (date received by manufacturer), g6 type or report - follow up# 1, h2 (correction, additional information, and device evaluation), h6: annex f (health effect - impact code), 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.

• 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: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 24407815
• Report Number: 1423507-2026-00032
• Device Sequence Number: 9905704
• Product Code: KNW
• UDI-Device Identifier: 10885403464157
• UDI-Public: (01)10885403464157(17)300630(10)0001628990
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 0001628990
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown