MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW; INSTRUMENT, BIOPSY

Model Number	DJ4011X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2022
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
Today i got a breakage complaint from the hemato-patho department of pgimer for 2 pcs dj4011x original jamshidi.Kindly find the attached pic of the needle and lot number and kindly share the recent complaint form to fill full information and submission.Dj4011x wes broken during 2 bone marrow biopsy cases, one broken inside and removed through surgery and one without surgery.Was the needle broken during use or identified before use.- its broken during use what was the impact on the patient? - the needle broke inside and the patient underwent a surgical procedure to remove the needle.Is there a sample available showing the reported issue? - yes.Was there any medical intervention required? - yes, undergone surgery to remove the needle.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one sample of lot 0001429233 and three photos were provided to our quality team for investigation.The sample was returned without the stylet, cap, or protective tubing.Through visual inspection, it was observed that the needle is broken.The upper half of the needle 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.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 0001429233 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.H3 other text : see manufacture narration.
Event or Problem Description
Today i got a breakage complaint from the hemato-patho department of pgimer for 2 pcs dj4011x original jamshidi.Kindly find the attached pic of the needle and lot number and kindly share the recent complaint form to fill full information and submission.29-nov-2022: received additional information from complainant.Malini dj4011x wes broken during 2 bone marrow biopsy cases, one broken inside and removed through surgery and one without surgery.30-nov-2022- received an email replies from complainant for information requested.Malini was the needle broken during use or identified before use.- its broken during use what was the impact on the patient? - the needle broke inside and the patient underwent a surgical procedure to remove the needle.Is there a sample available showing the reported issue? - yes.Was there any medical intervention required? - yes, undergone surgery to remove the needle.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW
• 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: 15906220
• Report Number: 9680904-2022-00037
• Device Sequence Number: 12110232
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K813338
• 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,Followup
• Report Date (Section B): 01/18/2023

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: 07/17/2026
• Device Model Number: DJ4011X
• Device Catalogue Number: DJ4011X
• Device Lot Number: 0001429233
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 01/18/2023
• 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