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

Catalog Number	16-SN3C231
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The client reports that the syringe plunger is stuck 1/2-3/4 of the way down the syringe when injecting and cannot continue to complete the injection.
Additional Manufacturer Narrative
The returned samples and retained samples were inspected, all of them met the specification, the dhr of this lot was reviewed without any issues.The root cause can't detected currently, no action will be taken.This issue will be monitored.A supplemental report will be submitted if further information received.

• Brand Name: MCKESSON
• Common Device Name: SYRINGE
• 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: 19102835
• Report Number: 3005670221-2024-00036
• Device Sequence Number: 7268022
• Product Code: FMF
• UDI-Device Identifier: 10612479207186
• UDI-Public: (01)10612479207186
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2024

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
• Device Catalogue Number: 16-SN3C231
• Device Lot Number: CJCA11-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 04/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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