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

Model Number 1ML 27GX1/2"

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The needle hub falls off when the syringe is administered to the patient with medication.

Manufacturer Narrative

So far, no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.Complaints received for this device and reported condition will continue to be tracked and trended.

• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD; no.23 huanxi road, zhutang; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer Contact: camel zhou ; no.23 huanxi road, zhutang; jiangyin, jiangsu 21441-5 ; CH 214415
• MDR Report Key: 18523330
• MDR Text Key: 332999616
• Report Number: 3005670221-2022-00013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1ML 27GX1/2"
• Device Catalogue Number: SYR101272
• Date Manufacturer Received: 07/27/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1