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

Catalog Number	TJM4011
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
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.Photos were provided and review is underway.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 that on (b)(6) 2025 eight jamshidi needles were identified containing some sort of foreign particles.No patient impact was reported.
Event or Problem Description
It was reported that on 22-sep-2025 eight jamshidi needles were identified containing some sort of foreign particles.No patient impact was reported.
Additional Manufacturer Narrative
H11: ten pouches and fourteen photos were received by our quality team for evaluation.Debris was observed within the sample pouches; however, the amount does not exceed the debris limit or failure criteria.Additionally, the debris is located in a non-critical area.Some of the photo appear to be magnified.Inspection for debris is performed using the naked eye.A review of the device history record (dhr) for part: tjm4011 lot: 0001552495 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.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.D9 (device available for eval; 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?), 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.

• Brand Name: JAMSHIDI
• 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: 23290436
• Report Number: 1423507-2025-00098
• Device Sequence Number: 10193566
• Product Code: KNW
• UDI-Device Identifier: 10885403044588
• UDI-Public: (01)10885403044588(11)240206(17)290131(10)0001552495
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/29/2025

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: TJM4011
• Device Lot Number: 0001552495
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown