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	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
Please find third product complaint regarding tin3015 jamshidi illinois aspiration needle 15g.Previous complaints were logged under (b)(4) and (b)(4).As i said this is the third product complaint, received from the same customer, relating to the same product.We already have a box awaiting tnt collection tomorrow.Could this be please escalated as it looks like every month we receive the same complaint.Could i ask you to check your records and retention samples and advise if any other complaint has been recorded and what corrective actions have been undertaken please.We need to communicate findings with our customer, it¿s been two months since we logged the very first complaint and we haven¿t heard of any investigation findings.
Event or Problem Description
Please find attached third product complaint regarding tin3015 jamshidi illinois aspiration needle 15g.Previous complaints were logged under ref.(b)(4) and ref.(b)(4).As i said this is the third product complaint, received from the same customer, relating to the same product.We already have a box awaiting tnt collection tomorrow.Could this be please escalated as it looks like every month we receive the same complaint.Could i ask you to check your records and retention samples and advise if any other complaint has been recorded and what corrective actions have been undertaken please.We need to communicate findings with our customer, it¿s been two months since we logged the very first complaint and we haven't heard of any investigation findings.
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.H3 other text: see manufacturer narrative.

• 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: 11294073
• Report Number: 1625685-2021-00014
• Device Sequence Number: 14327762
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 02/02/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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