MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS (TJ) NEEDLE ASPIRATION 15GA - TIN3015; BONE MARROW COLLECTION/TRANSFUSION KIT

Model Number	TIN3015
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
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 "needle puncturing through and poking staff." needle puncturing through and poking staff.What was the needle puncturing through? needle punctured through the surgical kits outer layers ¿ i.E., back table cover.Did the staff have any medical intervention? no.If sample is available, please provide address returning from (b)(6).
Event or Problem Description
It was reported that "needle puncturing through and poking staff".What was the needle puncturing through? needle punctured through the surgical kits outer layers ¿ i.E., back table cover.Did the staff have any medical intervention? no.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: one unused sample inside a sealed pouch was provided to our quality team for investigation.Through visual inspection, it is observed that the product inside the sealed pouch has the needle protector intact; therefore, the reported failure could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001402635 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.
Event or Problem Description
It was reported that "needle puncturing through and poking staff".Needle puncturing through and poking staff.What was the needle puncturing through? needle punctured through the surgical kits outer layers ¿ i.E., back table cover.Did the staff have any medical intervention? no.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one unused sample inside a sealed pouch was provided to our quality team for investigation.Through visual inspection, it is observed that the product inside the sealed pouch has the needle protector intact; therefore, the reported failure could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001402635 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.A corrective action project was opened to further investigate and address this issue.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.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 15GA - TIN3015
• 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: 13153781
• Report Number: 1625685-2022-00001
• Device Sequence Number: 19870389
• Product Code: LWE
• UDI-Device Identifier: 10885403043796
• UDI-Public: (01)10885403043796
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K930217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2026
• Device Model Number: TIN3015
• Device Catalogue Number: TIN3015
• Device Lot Number: 0001402635
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 04/04/2022; 05/02/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 04/04/2022; 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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