MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI EVOLVE (EJ) BONE MARROW NEEDLE; INSTRUMENT, BIOPSY

Model Number	EJM6011
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer they received three boxes of product but it had the wrong size description on the label.The product was labeled for size 11gx15cm but should have been for 11gx6cm.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a2101.Patient problem code: f27.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for correction- non mdr complaint: based on available information, dt application, and risk file, fmea or eura review; the potential risk of the reported event is not mdr reportable.One photo was received by our quality team for investigation.No issues with the label were identified.The current revision of the case label matches the reportedly defective label.Artwork for the bone marrow product lines (dj, tj, and ej) all reflect the length in centimeters.A device history record could not be evaluated as the lot number is unknown.
Event or Problem Description
Material no: ejm6011.It was reported by the customer they received three boxes of product but it had the wrong size description on the label.The product was labeled for size 11gx15cm but should have been for 11gx6cm.Verbatim: this customer received 3 boxes of ejm6011 which should be an 11g x 6cm.However, the packaging says ejm6011 but it has description listed at 11gx15cm.Pictures attached.Can you please assist with getting credit back to my sample account? omitted already sent the replacement.

• Brand Name: JAMSHIDI EVOLVE (EJ) BONE MARROW NEEDLE
• 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: 16731840
• Report Number: 1625685-2023-00036
• Device Sequence Number: 6843756
• Product Code: KNW
• UDI-Device Identifier: 10885403464171
• UDI-Public: (01)10885403464171
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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 Model Number: EJM6011
• Device Catalogue Number: EJM6011
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/21/2023
• 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