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

Catalog Number	DIN1518X
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
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), initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a2101.Patient problem code: f27.
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
Pr 8955822 follow-up emdr for device evaluation: related the missing label failure mode: two photos sample were provided to our quality team for evaluation.During visual inspection, the first picture shows a product pouch.There is no label on the pouch.The second picture shows the product inside the pouch.The product appears to be an illinois needle and the package appears sealed.No label can be seen on the transparent side of the product; therefore, the reported failure mode missing label was 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 quality team's investigation, it was identified that the probable root cause is traced to manufacturing related human error.A corrective action project was opened to further investigate these defects.Work instructions were reviewed for the revision that was released at the time of manufacture of the reported lot and it was observed that the work instructions have all the applicable process steps to perform the operation correctly.During the investigation process for corrective action and preventive action, it was determined that method and manpower related to work instructions were root causes for this non-conformance and machine related to the scanning process for the sealing system was listed as a contributing factor.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
(b)(4) follow-up emdr for device evaluation: related the missing label failure mode: one physical sample and two photos sample were provided to our quality team for evaluation.During visual inspection of the sample and the first picture shows a product pouch.The pouch has no label.The second picture shows the product inside the pouch.The product appears to be an illinois needle and the package appears sealed.No label can be seen on the transparent side of the product; therefore, the reported failure mode missing label was 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 quality team's investigation, it was identified that the probable root cause is traced to manufacturing related human error.A corrective action project was opened to further investigate these defects.Work instructions were reviewed for the revision that was released at the time of manufacture of the reported lot and it was observed that the work instructions have all the applicable process steps to perform the operation correctly.During the investigation process for corrective action and preventive action, it was determined that method and manpower related to work instructions were root causes for this non-conformance and machine related to the scanning process for the sealing system was listed as a contributing factor.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: 17923125
• Report Number: 9680904-2023-00036
• Device Sequence Number: 11508946
• 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