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

Catalog Number 16-N3005

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2022

Event Type  malfunction  

Event Description

It was reported by the customer that upon opening the needle, there appeared to be some type of foreign matter inside of the hub.There were also 5-6 needles that seemed to be mis-threaded.No information was received regarding any serious injury as a result of this report.

• 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: 15096629
• MDR Text Key: 296565895
• Report Number: 1451040-2022-00046
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-N3005
• Device Lot Number: CJCA08-01
• 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: 07/25/2022
• Distributor Facility Aware Date: 07/13/2022
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1