MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; NEEDLE, BLOOD COLL W/SFTY SHLD21GX1 1/4"

Catalog Number	16-NBC21GS
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that complaints had been received regarding the needles being problematic due to it tilting to the side and leaving the needle exposed.Technicians have expressed concerns about accidentally getting injured and have resorted to not activating the mechanism.Additionally, the safety mechanism does not open smoothly or fully, causing inconvenience during blood drawing and some of the larger tubes push off during a blood draw.This was reported to have occurred with the majority of the box on hand.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, BLOOD COLL W/SFTY SHLD21GX1 1/4"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 19059919
• Report Number: 1451040-2024-00014
• Device Sequence Number: 12269502
• Product Code: FMI
• UDI-Device Identifier: 20612479244331
• UDI-Public: 20612479244331
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024
• Report Date (Section F): 04/08/2024

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-NBC21GS
• 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: 03/15/2024
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2024
• 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: 04/08/2024