MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW 18G ADJ; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	DIN1518X
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0404.Patient problem code: f26.
Event or Problem Description
It was reported that, user found there was no product information label on the actual goods inside the box.It was reported that, the user suspects needle crack during use.It was observed air leakage.
Event or Problem Description
It was reported that, user found there was no product information label on the actual goods inside the box.It was reported that, the user suspects needle crack during use.It was observed air leakage.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: related to the cracked needle failure mode: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001427561 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.
Additional Manufacturer Narrative
Pr 8955822 follow-up emdr for device evaluation: related to the cracked needle failure mode: one physical sample of illinois needle was returned for evaluation in sealed package.The needle was visually inspected, and no cracks were observed; therefore, the failure mode of crack was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001427561 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, user found there was no product information label on the actual goods inside the box.It was reported that, the user suspects needle crack during use.It was observed air leakage.

• Brand Name: ILLINOIS NEEDLE BONE MARROW 18G ADJ
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17923123
• Report Number: 9680904-2023-00037
• Device Sequence Number: 2983249
• Product Code: FMI
• UDI-Device Identifier: 10885403087073
• UDI-Public: (01)10885403087073
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 01/16/2024

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: 07/05/2026
• Device Catalogue Number: DIN1518X
• Device Lot Number: 0001427561
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 01/16/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/30/2023; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown