MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS (TJ) NEEDLE ASPIRATION 18GA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	TIN3018
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
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.Device problem code: a0205.Patient problem code: f27.
Event or Problem Description
Needle unsheathed in packaging.We have had a safety concern regarding a carefusion illinios sternal/iliac needle 18g x 3" ref (b)(4) batch 0001493219 exp 30/09/27 the aspiration needle had become unsheathed from the safety tip and was poking out the side of the packet.This occurred inside the cardboard box packaging.It could have caused a needle stick injury.I have photos, if you require them.Marie dixon per followup: no patient involvement, it was found by haematology consultant and registrar.No needlestick injury occurred as they noticed it as they were pulling it out of the box, so not reported, other than to let me know to notify you.The physical needle was discarded immediately into a sharps bin to prevent anybody from harm.
Additional Manufacturer Narrative
Pr 8993984 follow-up emdr for device evaluation: two photos provided to our quality team for investigation.Through visual inspection, we can confirm that the assembly came apart, exposing the needle, which damaged the packaging.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001493219 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.Manufacturing personnel have been notified of this incident and awareness training will be 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
Needle unsheathed in packaging.We have had a safety concern regarding a carefusion illinios sternal/iliac needle 18g x 3" ref tin3018 batch 0001493219 exp 30/09/27 the aspiration needle had become unsheathed from the safety tip and was poking out the side of the packet.This occurred inside the cardboard box packaging.It could have caused a needle stick injury.I have photos, if you require them.Marie dixon per followup: no patient involvement, it was found by haematology consultant and registrar.No needlestick injury occurred as they noticed it as they were pulling it out of the box, so not reported, other than to let me know to notify you.The physical needle was discarded immediately into a sharps bin to prevent anybody from harm.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 18GA
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 17877627
• Report Number: 1625685-2023-00102
• Device Sequence Number: 7173065
• Product Code: FMI
• UDI-Device Identifier: 10885403043819
• UDI-Public: (01)10885403043819
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K930217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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 Catalogue Number: TIN3018
• Device Lot Number: 0001493219
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown