MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X4; INSTRUMENT, BIOPSY

Model Number	TJC4008
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported "concerning the bone marrow puncture needle, jamshidi reg tjc4008 lot 0001435436 2026-09-30, the diabolo to guide the needle in the right direction is blocked.2 cases were noted by the hematologist; 1 defective part is in the pharmacy".Concerning the bone marrow puncture needle, jamshidi reg tjc4008 lot 0001435436 2026-09-30, the diabolo allowing to guide the needle in the right direction is blocked.2 cases were noted by the hematologist who pricked herself following this problem; 1 defective part is in the pharmacy.Was there a need for medical intervention due to what happened (administration of medications, etc)? (detail) - no is there a photo or sample available showing the reported issue? - sample available.I have them at home.
Additional Manufacturer Narrative
Pr 4633454 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 0001435426 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 "concerning the bone marrow puncture needle, jamshidi reg tjc4008 lot 0001435436 2026-09-30, the diabolo to guide the needle in the right direction is blocked.2 cases were noted by the hematologist; 1 defective part is in the pharmacy".Concerning the bone marrow puncture needle, jamshidi reg tjc4008 lot 0001435436 2026-09-30, the diabolo allowing to guide the needle in the right direction is blocked.2 cases were noted by the hematologist who pricked herself following this problem; 1 defective part is in the pharmacy.Was there a need for medical intervention due to what happened (administration of medications, etc)? (detail) - no.Is there a photo or sample available showing the reported issue? - sample available.I have them at home.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one sample of lot: 0001435426 with a probe guide was provided to our quality team for investigation.Through visual inspection, the eight in 4008 (tjc4008) indicates this is an 8 ga product set.However, it was observed that the returned probe guide was a 13 ga.The two sizes are not complimentary in one product; therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number: 0001435426 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 the probable root cause was manufacturing related- inattention to detail.Awareness training will be conducted.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 manufacture narration.
Event or Problem Description
It was reported "concerning the bone marrow puncture needle, jamshidi reg tjc4008 lot: 0001435436 2026-09-30, the diabolo to guide the needle in the right direction is blocked.2 cases were noted by the hematologist; 1 defective part is in the pharmacy".Concerning the bone marrow puncture needle, jamshidi reg tjc4008 lot: 0001435436 2026-09-30, the diabolo allowing to guide the needle in the right direction is blocked.2 cases were noted by the hematologist who pricked herself following this problem; 1 defective part is in the pharmacy.Was there a need for medical intervention due to what happened (administration of medications, etc)? (detail) no.Is there a photo or sample available showing the reported issue? - sample available.I have them at home.

• Brand Name: JAMSHIDI (TJ) NEEDLE BONE MARROW 8G 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: 13770517
• Report Number: 1625685-2022-00039
• Device Sequence Number: 5008232
• Product Code: KNW
• UDI-Device Identifier: 10885403044038
• UDI-Public: (01)10885403044038
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: TJC4008
• Device Catalogue Number: TJC4008
• Device Lot Number: 0001435426
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/22/2022; 08/02/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/22/2022; 08/02/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown