MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE - EJM4011; INSTRUMENT, BIOPSY

Model Number	EJM4011
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 3883280 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code:(b)(6).
Event or Problem Description
It was reported that the inner measuring stick did not have measurement lines.Verbatim: it was reported that the inner measuring stick did not have measurement lines.Describe the event or problem: it was reported that the inner measuring stick did not have measurement lines.Manufacturer response for bone marrow biopsy needle, (brand not provided) (per site reporter) : none yet.What was the original intended procedure? : bone marrow biopsy.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001327171 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.H3 other text : see manufacturer here.
Event or Problem Description
It was reported that the inner measuring stick did not have measurement lines.Verbatim: it was reported that the inner measuring stick did not have measurement lines describe the event or problem: it was reported that the inner measuring stick did not have measurement lines.Manufacturer response for bone marrow biopsy needle, (brand not provided) (per site reporter) : none yet.What was the original intended procedure? : bone marrow biopsy.

• Brand Name: JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE - EJM4011
• 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: 12804133
• Report Number: 1625685-2021-00089
• Device Sequence Number: 12133651
• Product Code: KNW
• UDI-Device Identifier: 10885403464157
• UDI-Public: (01)10885403464157
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 09/30/2024
• Device Model Number: EJM4011
• Device Catalogue Number: EJM4011
• Device Lot Number: 0001327171
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 03/23/2022
• 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