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

Catalog Number	EJM4011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device was not return.The investigation is currently underway.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a bone marrow biopsy procedure, the white cap/handle part of the cradle came off.It was further reported that forceps were used to remove the device from the patient.There was no reported patient injury.Rcc received a complaint via email.We had an incident during a bone marrow procedure with item# ejm4011.When the physician assistant was collecting the biopsy, the white cap/handle part of the cradle came off.They were able to use forceps to grip the part and remove from the patient.Lot number: 0001578725.Date of manufacturer: 2024-07-18.
Additional Manufacturer Narrative
H10: manufacturing review: a lot number was provided so a device history record was performed.There was no recorded quality problems or rejections related to this incident found.All product procedural and functional requirements needed for its release were met.H10: investigation summary: a physical sample was not received for evaluation; therefore, a sample analysis was not possible.The result of the investigation was unable to confirm the reported failure mode.A definite root cause could not be determined.H10: b5 (describe event or problem), g4 (date received by manufacturer), g7 (type of report; follow up 1), h2 (correction; additional information).H11: d4 (unique identifier (udi) #), h4 (device manufacturing date), h6 (component code, investigation, investigation results, conclusions).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a bone marrow biopsy procedure, the white cap/handle part of the cradle came off.It was further reported that forceps were used to remove the device from the patient.There was no reported patient injury.Verbatim: rcc received a complaint via email.We had an incident during a bone marrow procedure with item# ejm4011.When the physician assistant was collecting the biopsy, the white cap/handle part of the cradle came off.They were able to use forceps to grip the part and remove from the patient.Lot number: 0001578725.Date of manufacturer: 2024-07-18.

• Brand Name: JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE
• 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: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20859105
• Report Number: 1625685-2024-00136
• Device Sequence Number: 4069748
• Product Code: KNW
• UDI-Device Identifier: 10885403464157
• UDI-Public: (01)10885403464157(11)240718(17)290630(10)0001578725
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/20/2025

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: EJM4011
• Device Lot Number: 0001578725
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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