MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP - DJ3513X; INSTRUMENT, BIOPSY

Model Number	DJ3513X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2021
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 needle tip broke off in patient during procedure.¿essentially during the procedure where the app was attempting to core the biopsy specimen, the entire tip (a little over 1 cm of length) broke off the needle in the patient¿s bone.Several attempts were made to remove the metal tip back out, but it was ultimately decided to leave in situ.This is the first time i have heard of this occurring, i was quite surprised to get that call.The itm number for the needle is itm-1120387 needle jamshidi 13g 3.5¿.This instance has a lot number of 0001418607.The remainder of the product is in the bag along with the packaging, it does have some blood on it as it was used on the patient so it is in a biohazard specimen bag.Tip left in patient at this time.Unsure if it will end up being problematic and causing harm.Causing additional procedure length, increased follow up care and potential future surgery to remove.
Additional Manufacturer Narrative
(b)(6) follow-up emdr for device evaluation: two photos and one sample of lot 0001418607 were provided to our quality team for investigation.During the evaluation it was observed that the needle is broken.The upper half of the cannula was inspected, and it was observed that the surface close to the breakage is bent, deformed and it appears as if excessive force was applied to the needle.Upon visual inspection of the photos, show an image of the tip of the needle inside the patient¿s body.A review of the internal manufacturing device records and raw material history files for reported lot 0001418607 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.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Material no.: dj3513x batch no.: 0001418607.It was reported that needle tip broke off in patient during procedure.Verbatim: tempe - needle jamshidi 13 ga 3.5in ¿ dj3513x; external reference # na; material #dj3513x - batch #0001418607.Email verbatim: ¿essentially during the procedure where the app was attempting to core the biopsy specimen, the entire tip (a little over 1 cm of length) broke off the needle in the patient¿s bone.Several attempts were made to remove the metal tip back out, but it was ultimately decided to leave in situ.This is the first time i have heard of this occurring, i was quite surprised to get that call.The itm number for the needle is itm-1120387 needle jamshidi 13g 3.5¿.This instance has a lot number of 0001418607.The remainer of the product is in the bag along with the packaging, it does have some blood on it as it was used on the patient so it is in a biohazard specimen bag.Tip left in patient at this time.Unsure if it will end up being problematic and causing harm.Causing additional procedure length, increased follow up care and potential future surgery to remove.Please see responses below: what was the procedure that was being performed? unilateral bone marrow biopsy and aspiration.How was item piece retrieved from patient/procedure? after multiple unsuccessful attempts at retrieval, it was decided to leave the foreign body (needle piece) in place.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? yes, x-ray.What was the impact to the patient? the patient has a retained foreign body due to the needle complication and will need continuous monitoring for complications as a result.Was the procedure completed as planned? yes.

• Brand Name: JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP - DJ3513X
• 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: 13052831
• Report Number: 9680904-2021-00115
• Device Sequence Number: 3902717
• Product Code: KNW
• UDI-Device Identifier: 10885403087110
• UDI-Public: (01)10885403087110
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 05/01/2026
• Device Model Number: DJ3513X
• Device Catalogue Number: DJ3513X
• Device Lot Number: 0001418607
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/31/2022
• 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