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

Catalog Number 102-SN1C31516P

Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)

Patient Problem Abscess (1690)

Event Date 12/15/2022

Event Type  Injury  

Event Description

Customer reported that the needles are barbed and bent upon opening and seem to be blocked.They will not even draw up water and upon initial injection often are not able to get any register.They are causing wounds, abscesses, and frequent misses.

• 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: 16550044
• MDR Text Key: 311371628
• Report Number: 1451040-2023-00013
• Device Sequence Number: 1
• Product Code: FMI
• 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: 03/15/2023,03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102-SN1C31516P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2023
• Distributor Facility Aware Date: 02/21/2023
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other