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

Model Number	DJ4011X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (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 that when needle was removed from patient, it was broken in the middle and surgeon had to remove it.There is a new case reported from facility representative that the device was broken apart at the middle.It was reported that, after the needle punctured into bone, the dr.Rotated the needle and removed it from patient.The needle was found broken apart at the middle.Another broken part was removed by the orthopedic surgeon.Please advise sending address and courier account for sending out the defected needle for inspection.Thank you.
Event or Problem Description
It was reported that when needle was removed from patient, it was broken in the middle and surgeon had to remove it.There is a new case reported from facility representative that the device was broken apart at the middle.Please find the information below for your reference: what was the procedure that was being performed? obtaining bone marrow biopsy from patient's pelvis.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, the cannula was found broken at the middle and about 5cm of it was left in the patient's body when the dr retrieved the cannula from the patient.An surgery was performed next day to retrieve the broken part of cannula from patient successfully.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.What was the patient¿s outcome? the patient stayed in the ward after the surgery to retrieve the broken cannula.Patient¿s condition was stable.Was the procedure completed as planned? no, the dr stopped the bone marrow biopsy procedure immediately after noticing the cannula was broken.Do you have photos of the reported issue on the instrument? yes.Please see attachment.It was reported that, after the needle punctured into bone, the dr.Rotated the needle and removed it from patient.The needle was found broken apart at the middle.Another broken part was removed by the orthopedic surgeon.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos and one sample were provided to our quality team for investigation.Through visual inspection, 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.The bottom half of the cannula was also inspected, 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.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001363779 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 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.H3 other text : see manufacturer here.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 12481521
• Report Number: 9680904-2021-00092
• Device Sequence Number: 3794045
• Product Code: KNW
• UDI-Device Identifier: 10885403087141
• UDI-Public: (01)10885403087141
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 05/01/2025
• Device Model Number: DJ4011X
• Device Catalogue Number: DJ4011X
• Device Lot Number: 0001363779
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other