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	05/10/2024
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 by customer that metal shavings from jamshidi.Verbatim: rcc received a complaint via email.Email(s) attached.Metal shavings from jamshidi.Customer response on aug 02, 2024.1.Could you please provide a further description of the issue? metal shavings flaked off from the jamshidi needle.2.When was this defect observed? during or before use? during 3.What was the impact to the patient? no.4.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.5.Can you please provide an exact date of event in format dd-mmm-yyyy? 05/010/2024.6.Any physical sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no.7.If possible, could you please provide picture samples for investigation? see photos 8.Was this reported earlier to bd? if yes, please provide complaint reference number.No.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos samples were received by our quality team for investigation.Upon visual inspection, we are unable to confirm the source of the reported shaving.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001515801 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 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.
Event or Problem Description
It was reported by customer that metal shavings from jamshidi.Verbatim: rcc received a complaint via email.Metal shavings from jamshidi.Customer response on aug 02, 2024.1.Could you please provide a further description of the issue? metal shavings flaked off from the jamshidi needle.2.When was this defect observed? during or before use? during.3.What was the impact to the patient? no.4.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.5.Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2024.6.Any physical sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no.7.If possible, could you please provide picture samples for investigation? see photos 8.Was this reported earlier to bd? if yes, please provide complaint reference number.No.

• 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: 19999690
• Report Number: 1625685-2024-00097
• Device Sequence Number: 4877606
• Product Code: KNW
• UDI-Device Identifier: 10885403044052
• UDI-Public: (01)10885403044052(11)230501(17)280430(10)0001515801
• 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): 10/03/2024

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: 0001515801
• 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: 10/03/2024
• Initial Report FDA Received Date: 08/19/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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