MAUDE Adverse Event Report: CAREFUSION, INC BONE MARROW 11GX4-15G MAC; INSTRUMENT, BIOPSY

Model Number	BEJS4511
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
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
It was reported that a component disconnected from biopsy needle.Verbatim: today one of our providers was performing a bone marrow biopsy and the white cap attached to the top of the bone marrow cradle popped up totally.It was not longer attached to the device.Luckily the provider was able to remove the cradle with a pair of kelly clamps and the core was also retrieved.The lot # for this kit is 0001432964 with an expiration date of 08/31/2022.What was the impact to the patient? was they able to complete the procedure successfully? through xxxx expertise he was able to successfully complete the procedure using a pair of kelly clamps to extract the broken bone marrow cradle.
Additional Manufacturer Narrative
Pr (b)(6) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, it was observed that the white cap is not attached 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 0001432964 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
It was reported that a component disconnected from biopsy needle.Verbatim: today one of our providers was performing a bone marrow biopsy and the white cap attached to the top of the bone marrow cradle popped up totally.It was not longer attached to the device.Luckily the provider was able to remove the cradle with a pair of kelly clamps and the core was also retrieved.The lot # for this kit is 0001432964 with an expiration date of (b)(6)2022.What was the impact to the patient? - was they able to complete the procedure successfully? through xxxx expertise he was able to successfully complete the procedure using a pair of kelly clamps to extract the broken bone marrow cradle.

• Brand Name: BONE MARROW 11GX4-15G MAC
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14021589
• Report Number: 1625685-2022-00044
• Device Sequence Number: 11421082
• Product Code: KNW
• UDI-Device Identifier: 10885403471582
• UDI-Public: (01)10885403471582
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: BEJS4511
• Device Catalogue Number: BEJS4511
• Device Lot Number: 0001432964
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 69 YR
• Patient Sex: Female