MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; NEEDLE, HYPO TW 18GX1"

Catalog Number 16-N181

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported by the customer that the needles are not fully locking onto the syringes.This led to an incident that while the practitioner was injecting blood into a bag of saline, the needle disconnected from the syringe, and the blood squirted all over the patient and the practitioner.

• Brand Name: MCKESSON BRANDS
• Type of Device: NEEDLE, HYPO TW 18GX1"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 18273054
• MDR Text Key: 329775643
• Report Number: 1451040-2023-00060
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 16-N181
• Device Lot Number: CKDA12-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2023
• Distributor Facility Aware Date: 11/16/2023
• Device Age: 23 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other