MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4; INSTRUMENT, BIOPSY

Catalog Number	TJC4011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that piece of the jamshidi needle flaking off.Verbatim: rcc received a complaint via email.Email(s) attached.Piece of the jamshidi needle flaking off.Follow-up: customer response on (b)(6) 2024.1.Could you please provide a further description of the issue? it was reported that the ¿metal pieces flaked off¿ into the specimen.2.When was this defect observed? during or before use? during use.3.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? for both lot # 0001515801 and 0001508587.No medical intervention, serious injury, or follow-up care has been reported.4.Can you please provide an exact date of event in format dd-mmm-yyyy for both lot # 0001515801 and 0001508587? exact dates not available.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0401.Patient problem code: f26.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos, two needles and metal shaving sample were provided to our quality team for investigation.Through visual inspection, the presence of a metal shaving within the sample was observed.No additional flaking was observed regarding the needles.The one photo is of the cannula, no issues were seen.The shaving was sent off for additional lab analysis.As a result of the lab analysis, it was concluded that the shavings share a closer relationship with the metal hub provided than with the unknown metal shavings, verifying the reported failure.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001508587 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.In conclusion we have found that the cause of the detached metal shaving found within the biopsy sample came from the hub supplier.Based on the quality team's investigation, it was identified that the probable root cause is traced to supplier related failure.A supplier corrective action request has been sent to the supplier.Awareness training has been performed with the incoming inspection team regarding this complaint.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.
Event or Problem Description
It was reported by customer that piece of the jamshidi needle flaking off.Verbatim: rcc received a complaint via email.Piece of the jamshidi needle flaking off.Follow-up: customer response on (b)(6) 2024.1.Could you please provide a further description of the issue? it was reported that the ¿metal pieces flaked off¿ into the specimen.2.When was this defect observed? during or before use? during use.3.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? for both lot # 0001515801 and 0001508587.No medical intervention, serious injury, or follow-up care has been reported.4.Can you please provide an exact date of event in format dd-mmm-yyyy for both lot # 0001515801 and 0001508587? exact dates not available.

• Brand Name: JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4
• 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: 19436159
• Report Number: 1625685-2024-00056
• Device Sequence Number: 8487566
• Product Code: KNW
• UDI-Device Identifier: 10885403044052
• UDI-Public: (01)10885403044052(11)230301(17)280229(10)0001508587
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: TJC4011
• Device Lot Number: 0001508587
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown