MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; NEEDLE, HYPO TW 25GX1 1/2"

Catalog Number	16-N25105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a needle broke off at the hub and was retained inside a patient.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE, HYPO TW 25GX1 1/2"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no.658; gaochao rd; jiading, shanghai 20180 3; CH 201803
• MDR Report Key: 24066656
• Report Number: 1451040-2026-00004
• Device Sequence Number: 9240907
• Product Code: FMI
• UDI-Device Identifier: 10612479206769
• UDI-Public: 10612479206769
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/14/2026
• Report Date (Section F): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 16-N25105
• Device Lot Number: CKDE07-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2026
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/14/2026