MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; NEEDLE, HYPO RW 30GX1/2"

Catalog Number	16-N3005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during a numbing procedure.The needle came out of the plastic hub as the nurse practitioner was retracting the needle after the procedure.No information was received regarding any serious injury as a result of this reported issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, HYPO RW 30GX1/2"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 19613496
• Report Number: 1451040-2024-00032
• Device Sequence Number: 20576493
• Product Code: FMI
• UDI-Device Identifier: 10612479207384
• UDI-Public: 10612479207384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/26/2024
• Report Date (Section F): 06/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 16-N3005
• Device Lot Number: CKDC10-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2024
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2024