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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

Fda received report (b)(4) through the medsun program and emailed cypress on 12/15/2022.

Event Description

It was reported that the physician assistant was going to numb a patient for a shave biopsy with 1% lidocaine.The needle was uncapped and upon inspecting the bevel of the needle prior to injection, a red liquid was noted in the bevel.A small amount of lidocaine was pushed out on a piece of gauze to confirm red liquid was inside the needle.The syringe was not used on the patient.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: 16129948
• MDR Text Key: 306989219
• Report Number: 1451040-2023-00001
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: CJCB03-01
• 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: 01/09/2023
• Distributor Facility Aware Date: 12/15/2022
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1