MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BM11G X3.5 ASP MAC; 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	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
1 ev with 10 pcs of lot: 0001560431 (1 pc with presence of foreign body; small plastic particles) is rejected.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a1801.Patient problem code: f26.H10: the lot number for the device was provided.The device history records are currently under review.The device has not been returned.The investigation is currently underway.H11: 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
1 ev with 10 pcs of lot: 0001560431 (1 pc with presence of foreign body; small plastic particles) is rejected.
Additional Manufacturer Narrative
H10 : one photo was provided.We were unable to definitively confirm the presence of debris.A review of the internal manufacturing device records 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.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.No issues or failures regarding debris were recorded as a result of the quality inspection of the finished good assembly.A failure could not be confirmed, as a result a root cause could not be determined.Awareness training was performed with the manufacturing team in an effort to raise awareness.H11: 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 (TJ) NEEDLE BM11G X3.5 ASP MAC
• 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_old ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 21274328
• Report Number: 1625685-2025-00008
• Device Sequence Number: 20850898
• Product Code: KNW
• UDI-Device Identifier: 10885403044588
• UDI-Public: (01)10885403044588(11)240322(17)290228(10)0001560431
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 0001560431
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown