MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; ALLERGIST TRAY, 1CC 27GX1/2"

Catalog Number 16-SNALL1C27

Device Problems Leak/Splash (1354); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  malfunction  

Event Description

It was reported by the customer that the needles are too blunt and are causing pain and swelling.In addition, when the staff draws up the serum, it pushes the serum out without pressing the plunger resulting in leakage of medication.No information was received regarding any serious injury as a result of these reported issues.

• Brand Name: MCKESSON BRANDS
• Type of Device: ALLERGIST TRAY, 1CC 27GX1/2"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 18013289
• MDR Text Key: 326633276
• Report Number: 1451040-2023-00051
• Device Sequence Number: 1
• Product Code: FMF
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-SNALL1C27
• Device Lot Number: CKDC04-01
• 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: 10/26/2023
• Distributor Facility Aware Date: 10/04/2023
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1