MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; SYRINGE, INSULIN 1CC 31GAX5/16"

Catalog Number 102-SN1C31516P

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

Customer reported that the syringes are loose resulting in leakage.No information was received regarding any serious injury as a result of these product issues.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE, INSULIN 1CC 31GAX5/16"
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no. 23 huanxi rd; zhutang town, jiangyin city ; CH
• MDR Report Key: 18317385
• MDR Text Key: 330363590
• Report Number: 1451040-2023-00062
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2023

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 Operator: Health Professional
• Device Catalogue Number: 102-SN1C31516P
• Device Lot Number: CJCB02-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2023
• Distributor Facility Aware Date: 11/20/2023
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1