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

Model Number	TJM4011
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Where during the control a blue plastic debris was noticed.He observed the presence of "blue" colored particles (inside the individual packaging) which would appear to be "debris" of blue plastic from the device.The manufacturer is required to justify the presence and harmlessness of these "debris".
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: five photos were provided to our quality team for investigation.Through visual inspection of the photos indicate blue foreign matter that is larger than 0.80 square millimeters, the cut off point for flash size.The size of these particles is over the limit when checked during the tappi particle size evaluation therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001394942 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 information provided, a probable root cause is inattention to detail for this investigation.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.
Event or Problem Description
Where during the control a blue plastic debris was noticed.He observed the presence of "blue" colored particles (inside the individual packaging) which would appear to be "debris" of blue plastic from the device.The manufacturer is required to justify the presence and harmlessness of these "debris".

• 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: 13670643
• Report Number: 1625685-2022-00034
• Device Sequence Number: 12011060
• Product Code: KNW
• UDI-Device Identifier: 10885403044588
• UDI-Public: (01)10885403044588
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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): 04/15/2022

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 Expiration Date: 11/30/2025
• Device Model Number: TJM4011
• Device Catalogue Number: TJM4011
• Device Lot Number: 0001394942
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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