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

Catalog Number	1186000444
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the seal is not working and the formula is coming out.
Additional Manufacturer Narrative
The returned samples and lot number of this event was requested but hasn't been received till now, no sample for evaluation and no dhr for review.The issue 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 lot number 231201 was provided by customer.We found that the customer feedback indicates that the production lot number is not produced by caina, so there is no need for further investigation.
Event or Problem Description
On september 10, 2024, the customer updated the production batch number of the product to 231201.
Event or Problem Description
On (b)(6) 2024, the customer updated the production batch number to cn231201.
Additional Manufacturer Narrative
After checking all sales orders, confirm that cn231201 is produced by caina, but we have already investigated this batch of retained samples on september 6, 2024, no abnormalities were found in the product, and the product quality meets the requirements of the product specifications, so there is no need for further investigation, the reasons and measures remain unchanged.No action will be taken currently, this issue will be monitored.A supplemental report will be submitted if further information received.

• Brand Name: CARDINAL
• Common Device Name: IRRIGATING 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: 20164752
• Report Number: 3005670221-2024-00269
• Device Sequence Number: 15274431
• Product Code: KYZ
• UDI-Device Identifier: 10192253034714
• UDI-Public: 0110192253034714
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/18/2024

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: 1186000444
• Device Lot Number: CN231201
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 10/07/2024
• Initial Report FDA Received Date: 09/07/2024
• Supplement Report FDA Received Date: 09/28/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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