MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC - TJM4008; INSTRUMENT, BIOPSY

Model Number	TJM4008
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Iron filings found in the trocar (sealed in the bag for visualization) to our knowledge, the patient was not involved.
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code: (b)(4).
Event or Problem Description
Iron filings found in the trocar (sealed in the bag for visualization).To our knowledge, the patient was not involved.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo and one sample were provided to our quality team for investigation.Through visual inspection, it is observed a sliver approximately 3 quarters of an inch in length with a width approximately the same as a pencil lead.The small sliver was examined under magnification.The physical characteristics of the item indicated it was partially metal of 2 or more colors and magnetic.Therefore, the reported failure mode was confirmed.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacture narration.

• Brand Name: JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC - TJM4008
• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14454423
• Report Number: 1625685-2022-00056
• Device Sequence Number: 17272732
• Product Code: KNW
• UDI-Device Identifier: 10885403044564
• UDI-Public: (01)10885403044564
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K913306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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 Model Number: TJM4008
• Device Catalogue Number: TJM4008
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown