MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BM 11G X3.5 ASP MAC; INSTRUMENT, BIOPSY

Model Number	TJM4011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
After the biopsy, the needle was broken in the patient's body while removing the needle what was the procedure that was being performed? bone marrow biopsy aspiration.How was item piece retrieved from patient/procedure? the surgeon conducted another surgery to retrieve the broken piece.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? a ct scan photo is attached.What was the impact to the patient? tbc was the procedure completed as planned? tbc is there a photo or sample available showing the reported issue for the evaluation? as attached.
Event or Problem Description
After the biopsy, the needle was broken in the patient's body while removing the needle - what was the procedure that was being performed? bone marrow biopsy aspiration.- how was item piece retrieved from patient/procedure? the surgeon conducted another surgery to retrieve the broken piece.
Additional Manufacturer Narrative
Pr 3816904 follow-up emdr for device evaluation: three photos and one sample were provided to our quality team for investigation.Through visual inspection, broken needle was observed therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the lot 0001397196 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.Based on the quality team's investigation, it was determined that the probable root cause is incorrect use by the end user.We appreciate you taking the time to bring this observation to our attention.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 manufacturer here.

• Brand Name: JAMSHIDI (TJ) NEEDLE BM 11G 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12740192
• Report Number: 1625685-2021-00078
• Device Sequence Number: 4126708
• Product Code: KNW
• UDI-Device Identifier: 10885403044588
• UDI-Public: (01)10885403044588
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K003370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TJM4011
• Device Catalogue Number: TJM4011
• Device Lot Number: 0001397196
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 03/14/2022
• 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