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

Catalog Number	16-S20C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned samples was requested but hasn't been received till now, the lot number of this event was received, the dhr of this lot was reviewed without any issues.The retained samples of the lot was tested and the samples met the specification.The root cause can't detected currently, no action will be taken currently, a supplemental report will be submitted if further information received.
Event or Problem Description
The customer reported that cracked barrel, drug leakage during drug delivery.

• 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: 19102803
• Report Number: 3005670221-2024-00055
• Device Sequence Number: 15305570
• Product Code: FMF
• UDI-Device Identifier: 10612479206912
• UDI-Public: (01)10612479206912
• 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
• Remedial Action: Recall
• 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-S20C
• Device Lot Number: CJCB02-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 04/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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