MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS (TJ) NEEDLE ASPIRATION 15GA; BONE MARROW COLLECTION/TRANSFUSION KIT

Model Number	TIN3015
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
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.
Event or Problem Description
Hi, i have just had a complaint reported to me that six bone biopsy needles have failed in (b)(6).(b)(4) jamshidi needle lot tbc.(b)(6).More details to follow in the morning.More details received: further to our conversation, we have had a product complaint today from our biggest user of code (b)(4), lot 0001374321.The customer has received 20 boxes of this batch since the beginning of october and they estimate they have approx.9 boxes remaining.Iskus have no stock of this needle and are awaiting a shipment this friday of same.The user was carrying out a biopsy and they stated ¿the tip of the needle bent and so we were unable to properly obtain a sample from the patient.It seems to render the needle blunt so the needle cannot get through the bone and obtain an aspirate sample.This happened to three needles during the procedure.¿ having enquired with the user and another doctor who uses the needle, it appears there have been 6 needles where this has happened over the past month.The customer would like us to remove the remaining stock and replace with a different batch, as they don¿t want to have this issue happen again with another patient.We will send on our official complaint document tomorrow and as agreed, we will ask the customer to keep the 3 needles in question so we can send them back.Also when we receive our stock on friday, we will consult with the customer and organise to remove any remaining stock of the batch in question.
Additional Manufacturer Narrative
(b)(4).Follow up emdr for device evaluation: ten unused samples along with several photos were provided to our quality team for investigation.Through visual inspection of the photos, the tip of the needles are observed to be bent, verifying the reported issue.The returned product underwent additional evaluations, no damage or defects were observed on the product and all samples were verified to meet dimensional requirements.A review of the internal manufacturing device records for lot 0001374321was performed and no recorded quality problems or rejections related to this incident were found.Based on the quality team's investigation, we cannot identify a root cause related to our manufacturing process at this time.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 manufacturer narrative.
Event or Problem Description
Hi i have just had a complaint reported to me that six bone biopsy needles have failed in ireland.Code tin3015 jamshidi needle lot tbc reported by eoin dunne from iskus health who distribute these in ireland.More details to follow in the morning.More details received: further to our conversation, we have had a product complaint today from our biggest user of code tin3015, lot 0001374321.The customer has received 20 boxes of this batch since the beginning of october and they estimate they have approx.9 boxes remaining.Iskus have no stock of this needle and are awaiting a shipment this friday of same.The user was carrying out a biopsy and they stated ¿the tip of the needle bent and so we were unable to properly obtain a sample from the patient.It seems to render the needle blunt so the needle cannot get through the bone and obtain an aspirate sample.This happened to three needles during the procedure.¿ having enquired with the user and another doctor who uses the needle, it appears there have been 6 needles where this has happened over the past month.The customer would like us to remove the remaining stock and replace with a different batch, as they don¿t want to have this issue happen again with another patient.Please see the photos below.We will send on our official complaint document tomorrow and as agreed, we will ask the customer to keep the 3 needles in question so we can send them back.Also when we receive our stock on friday, we will consult with the customer and organise to remove any remaining stock of the batch in question.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 15GA
• Common Device Name: BONE MARROW COLLECTION/TRANSFUSION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11082788
• Report Number: 1625685-2020-00102
• Device Sequence Number: 14440566
• Product Code: LWE
• UDI-Device Identifier: 10885403043796
• UDI-Public: (01)10885403043796
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K930217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 06/30/2025
• Device Model Number: TIN3015
• Device Catalogue Number: TIN3015
• Device Lot Number: 0001374321
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 09/10/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other