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

Catalog Number	EJM3513
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the bone marrow biopsy procedure during use of the jamshidi needle, some thin layer peeled away from the needle after the needle was removed from the patient.It was further reported that two core samples were obtained with the same needle, but one core sample was fragmented.Despite these issues the core samples were collected, and the patient was discharged from the hospital.There was no patient impact.
Additional Manufacturer Narrative
H11: h3 (device eval by manufacturer) a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.A photo was provided for evaluation.The photo review is 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.
Additional Manufacturer Narrative
H11: the lot number for the device was provided.A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.One sample and one photo was provided for analysis regarding debris.During sample and photo evaluation, the results of the investigation confirmed the presence of a fibrous debris.The source of the debris was unable to be confirmed.A definite root cause could not be determined.The material did not appear to be associated with materials provided within this finished product.D9 (device available for eval? and returned to manufacturer on), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction, additional information, and device evaluation), h3 (device eval by manufacturer?), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions), initial mdr mfr report # 1625685-2025-00068, site legal name (fda) reported, carefusion 2200, inc.- mannford, ok / 74044; site registration number (fda) (b)(4).Correct site legal name (fda) is, vernon hills; site registration number (fda) (b)(4).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 during the bone marrow biopsy procedure during use of the jamshidi needle, some thin layer peeled away from the needle after the needle was removed from the patient.It was further reported that two core samples were obtained with the same needle, but one core sample was fragmented.Despite these issues the core samples were collected, and the patient was discharged from the hospital.There was no patient impact, and the patient was successfully treated.

• Brand Name: JAMSHIDI EVOLVE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• 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: 22493968
• Report Number: 1625685-2025-00068
• Device Sequence Number: 8094190
• Product Code: KNW
• UDI-Device Identifier: 10885403464126
• UDI-Public: (01)10885403464126(11)230103(17)271231(10)0001501295
• 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): 10/20/2025

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: EJM3513
• Device Lot Number: 0001501295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown