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

Catalog Number	EJC4011
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the opening and the collection syringe did not build up negative pressure, so that no liquid bone marrow could be obtained.The incident occurred during use.Three needles from two different boxes from this batch for the bone marrow punctures and no negative pressure could be built up via the opening and the extraction syringe, so that no liquid bone marrow could be obtained.Alternative puncture needles from another company were available and were successfully used for the procedure.There was no patient harm was reported.No additional medical intervention was required, and there were no delays in diagnostics, treatment, or procedures.During the investigation, the sample analysis observed a hole in the weld.
Additional Manufacturer Narrative
H11: four photos and two needle samples one used and one unopened were provided to our quality team for investigation.The returned, used needle was confirmed to have a hole in the weld during functional testing, whereas the needle from the unopened pouch showed no issues.As part of the evaluation, and in accordance with the instructions for use (ifu), a syringe was attached to the cannula hub.This allowed us to replicate the reported failure: the collection syringe did not build up negative pressure, and no liquid bone marrow could be obtained.Upon removing the needle handle, a hole in the weld was observed, confirming the reported issue.However, we are unable to confirm the failure given the four photos.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001611385 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 quality team's investigation, it was identified that the probable root cause is traced to manufacturing related.H4: device manufacturing date 02/26/2025.Manufacturing date obtained from investigation record.D4: medical device expiration date: 01/31/2030.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.

• Brand Name: JAMSHIDI (EJ) NEEDLE BONE MARROW 11GX4
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• 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: 23513039
• Report Number: 1423507-2025-00140
• Device Sequence Number: 21356660
• Product Code: KNW
• UDI-Device Identifier: 10885403464065
• UDI-Public: (01)10885403464065
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: EJC4011
• Device Lot Number: 0001611385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/10/2025
• 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
• Patient Sex: Unknown