MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; NEEDLE, HYPO RW 30GX1/2"

Catalog Number 102-SN05C31516P

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

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

Event Type  malfunction  

Event Description

Customer reported that when using the needles, they fall off the syringe.This was reported to have occurred several times.When asked, customer indicated that the medication sometimes leaked when this occurred, and they had to keep changing the needles.No information was received regarding any serious injury as a result of these product issues.

• Brand Name: MCKESSON BRANDS
• Type of Device: NEEDLE, HYPO RW 30GX1/2"
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no. 23 huanxi rd; zhutang town, jiangyin city ; CH
• MDR Report Key: 18444769
• MDR Text Key: 331903252
• Report Number: 1451040-2024-00001
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102-SN05C31516P
• Device Lot Number: CJCA10-01
• 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: 01/04/2024
• Distributor Facility Aware Date: 12/14/2023
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1