MAUDE Adverse Event Report: WHELE LLC / CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD. CARTRIDGE 3ML RG MEDICATION; ACCESSORIES, PUMP, INFUSION

Lot Number (10)210408

Device Problem Device Alarm System (1012)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

Inbound; cadd rg3 pump alarming low volume when there is about 1ml of medication left in syringe.Syringe lot (10)210408, exp 04/07/2026.No further details provided.

• Brand Name: CARTRIDGE 3ML RG MEDICATION
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): WHELE LLC / CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
• MDR Report Key: 13282994
• MDR Text Key: 284107159
• Report Number: MW5106704
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: (10)210408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male