MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP -DJ4011X; INSTRUMENT, BIOPSY

Model Number	DJ4011X
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
An osteomedullary biopsy was performed on (b)(6) 2021 at 1pm in an intensive care patient.When the trocar was mobilised to break the biopsy core, 2-3 cm of trocar broke in the right posterior iliac spine.Impossible to recover the material.After getting an advice, leave the material in place.Consequences: noted 3 which corresponds to with transient damage (physical or mental) to the patient (regressed before discharge and without the initially planned hospitalization being prolonged by more than 48 hours) clinical consequences observed : impossible to recover the material.Conservative measures and actions taken: after ortho advice, leave the material in place.Unfortunately, the material could not be removed from the patient.
Event or Problem Description
An osteomedullary biopsy was performed on (b)(6) 2021 at 1pm in an intensive care patient.When the trocar was mobilized to break the biopsy core, 2-3 cm of trocar broke in the right posterior iliac spine.Impossible to recover the material.After getting an advice, leave the material in place.Consequences: noted 3 which corresponds to with transient damage (physical or mental) to the patient (regressed before discharge and without the initially planned hospitalization being prolonged by more than 48 hours).Clinical consequences observed : impossible to recover the material.Conservative measures and actions taken: after ortho advice, leave the material in place.Unfortunately, the material could not be removed from the patient.
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 0001058285 was performed and no recorded quality problems or rejections related to this incident were found.A review of machine records verified that all preventative maintenance was performed according to procedure and machine parameters were within required limits.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, we cannot identify a root cause related to our manufacturing process at this time.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.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP -DJ4011X
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 11748246
• Report Number: 9680904-2021-00052
• Device Sequence Number: 4356995
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 01/03/2022
• Device Model Number: DJ4011X
• Device Catalogue Number: DJ4011X
• Device Lot Number: 0001058285
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other