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

Model Number	TIN3018
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Improperly mounted protection on the trocar leading to a perforation of the packaging.Clinical consequences observed: very high risk of injury, but no actual injury reported precautionary measures and actions taken: withdrawal from stock.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: (b)(4).Patient problem code: (b)(4).
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos and one sample were provided to our quality team for investigation.Through visual inspection, it was observed that the protector had become detached, and that the needle had punctured the pouch, the sterile barrier had been compromised 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 0001390010 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 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.H3 other text: see manufacture narration.
Event or Problem Description
Improperly mounted protection on the trocar leading to a perforation of the packaging.Clinical consequences observed: very high risk of injury, but no actual injury reported precautionary measures and actions taken: withdrawal from stock.Device available for expertise by the supplier: yes.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 18GA
• 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: 15642551
• Report Number: 1625685-2022-00093
• Device Sequence Number: 6463396
• Product Code: LWE
• UDI-Device Identifier: 10885403043819
• UDI-Public: (01)10885403043819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K913306
• 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
• Report Date (Section B): 02/10/2023

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 Expiration Date: 09/30/2025
• Device Model Number: TIN3018
• Device Catalogue Number: TIN3018
• Device Lot Number: 0001390010
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 02/10/2023
• 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