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

Model Number	TIN3015
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4): initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
The tip of the needle bent as per previous complaint no.(b)(4).
Event or Problem Description
The tip of the needle bent as per previous complaint no.(b)(4).
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: no photos or physical samples of lot 0001379319 which display the reported condition were received for investigation.A device history review was performed and found no non-conformances related to this issue for lot 0001379319, all procedural and functional requirements were verified to have been properly met prior to release of the product.Based on the available information we are not able to determine a root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• 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: 11292894
• Report Number: 1625685-2021-00011
• Device Sequence Number: 3500240
• 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,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 07/31/2025
• Device Model Number: TIN3015
• Device Catalogue Number: TIN3015
• Device Lot Number: 0001379319
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 07/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other