MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS (TJ) NEEDLE ASPIRATION 18GA- TIN3018; BONE MARROW COLLECTION/TRANSFUSION KIT

Model Number	TIN3018
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
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
The needle packaging was opened and you can clearly see the needle has not been finished in production as the parts are separate.The blue handle is not attached.Pictures attached and the sample can be returned if required? not used on patient.The outer package was unopened and sealed appropriately.When we opened the package, we found the faulty item inside.The needle packaging was intact and sealed.1st attempt 4th nov 2021.Please reach out and request to verify the following: - was the package or pouch which contain needle seal was opened? - or the outer carton or the box was not sealed properly? - is there photo or sample available showing the package was opened?.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the sample, it was observed that the product kit contains an extra handle intentionally, possibility provides for incomplete assembly, 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 0001389683 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 and photo analysis the symptom reported by the customer is confirmed.Manufacturing personnel have been notified of this incident and additional training was provided.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.
Event or Problem Description
The needle packaging was opened and you can clearly see the needle has not been finished in production as the parts are separate.The blue handle is not attached.Pictures attached and the sample can be returned if required? not used on patient.The outer package was unopened and sealed appropriately.When we opened the package, we found the faulty item inside.The needle packaging was intact and sealed.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 18GA- TIN3018
• Common Device Name: BONE MARROW COLLECTION/TRANSFUSION KIT
• 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: 12829172
• Report Number: 1625685-2021-00091
• Device Sequence Number: 13833074
• Product Code: LWE
• UDI-Device Identifier: 10885403043819
• UDI-Public: (01)10885403043819
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K913306
• 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): 03/31/2022

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: 09/30/2025
• Device Model Number: TIN3018
• Device Catalogue Number: TIN3018
• Device Lot Number: 0001389683
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 03/31/2022
• 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 Sex: Unknown