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

Model Number	DJ4011X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During procedure needle got stuck inside and topmost part of the needle got broken and stuck inside only.How was item piece retrieved from patient/procedure?- it was still inside(broken part) of the patient.What was the impact to the patient? was the patient injured?-yes, patient is still injured.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code: (b)(6).
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: five photos and one sample was provided to our quality team for investigation.During the evaluation it was observed that the cannula is broken.The upper half of the cannula was inspected, and it was observed that the surface close to the breakage is bent and appears deformed and it was observed that the cut has jagged edges, the surface is rough and deformed and it appears as if excessive force was applied to the needle.The bottom half was not returned.A review of the internal manufacturing device records and raw material history files for reported lot 0001356416 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.The quality tests related to this incident were reviewed.This procedure calls for the visual inspection of the device to be free of damages or defects that could affect the quality and functionality of the product.No issues were found regarding the performed tests.Based on the investigation performed, a probable root cause cannot be established since during the analysis performed to all the elements relevant to the failure mode no issues were found.Complaints received for this device and defect will continue to be monitored for future occurrences.
Event or Problem Description
During procedure needle got stucked inside and topmost part of the needle got broken and stucked inside only.How was item piece retrieved from patient/procedure? it was still inside(broken part) of the patient.What was the impact to the patient? was the patient injured? yes, patient is still injured.

• 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
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12984001
• Report Number: 1423507-2021-00053
• Device Sequence Number: 14777732
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 03/17/2025
• Device Model Number: DJ4011X
• Device Catalogue Number: DJ4011X
• Device Lot Number: 0001356416
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/12/2022
• 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