MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON; NEEDLE

Catalog Number	16-N211
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer claims that the needle is pulling the vial cap into the iv solution (coring issue).
Additional Manufacturer Narrative
The returned samples of this event was requested but hasn't been received till now, no sample for evaluation.Customer feedback photo analysis result.There is a black foreign object inside the syringe.The dhr of this lot was reviewed without any similar issue, the retained samples were inspected and they all meet the specification.The event can't be confirmed, the root cause can't detected currently.No action will be taken currently, this issue will be monitored.A supplemental report will be submitted if further information received.
Additional Manufacturer Narrative
The returned samples of this event was received.The dhr was reviewed without any similar issue, the retained sample was tested and meet the specification.The returned sample was tested and they met the specificaiton.The issue can't be confirmed, the root cause can't detected currrently.No action will be taken currently, this issue will be monitored.A supplemental report will be submitted if further information received.
Event or Problem Description
(b)(6) 2024, we received (b)(4) samples returned by the customer.After investigating the returned samples.

• Brand Name: MCKESSON
• Common Device Name: NEEDLE
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer (Section G): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer Contact: camel zhou ; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441-5 ; CH 214415
• MDR Report Key: 20164756
• Report Number: 3005670221-2024-00268
• Device Sequence Number: 7282433
• Product Code: FMI
• UDI-Device Identifier: 10612479206615
• UDI-Public: 0110612479206615
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K172938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: Other
• Device Catalogue Number: 16-N211
• Device Lot Number: CJCD03-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/07/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown