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	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (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.
Event or Problem Description
It was reported metal shavings from jamshidi.Verbatim: rcc received a complaint via email.Email(s) attached.Defect description: metal shavings from jamshidi.Response received : august 5, 2024.1.Kindly provide the material number and batch/lot number of the product.500357 / unknown lot 2.Kindly provide the date of event.5/16/2024 3.Can you share any physical sample if available for investigation? if yes, please provide the address of the facility for us to ship the return label? no physical sample available 4.Could you please provide a further description of the issue? component flaked metal pieces off onto the bone biopsy sample 5.When was this defect observed? during or before use? during 6.If possible, could you please provide picture samples for investigation? customer response received please find the below file.1.What was the impact to the patient? no complication stated.2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.3.Was this issue reported earlier to bd? if yes, please provide complaint reference number.There was an earlier complaint reported in may (200615080/ pr (b)(4)) however, this is a separate incident with its own mdr reference number.
Event or Problem Description
It was reported metal shavings from jamshidi.Verbatim: rcc received a complaint via email.Defect description: metal shavings from jamshidi.Response received : august 5, 2024.1.Kindly provide the material number and batch/lot number of the product.500357 / unknown lot.2.Kindly provide the date of event.(b)(6) 2024.3.Can you share any physical sample if available for investigation? if yes, please provide the address of the facility for us to ship the return label? no physical sample available.4.Could you please provide a further description of the issue? component flaked metal pieces off onto the bone biopsy sample.5.When was this defect observed? during or before use? during.6.If possible, could you please provide picture samples for investigation? customer response received please find the below file.1.What was the impact to the patient? no complication stated.2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.3.Was this issue reported earlier to bd? if yes, please provide complaint reference number.There was an earlier complaint reported in may (b)(4) however, this is a separate incident with its own mdr reference number.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, we are unable to definitively confirm the source of the reported shaving; therefore, the reported failure mode was not confirmed.A device history record could not be evaluated as the lot number is unknown.Based on the available information we are not able to identify a root cause at this time.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.

• 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: 20024296
• Report Number: 1625685-2024-00096
• Device Sequence Number: 15595086
• Product Code: KNW
• UDI-Device Identifier: 10885403044052
• UDI-Public: (01)10885403044052
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/02/2024

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/02/2024
• 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