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

Lot Number 4122813

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2022

Event Type  malfunction  

Event Description

Inbound.Patient reporting low cartridge alarms with cadd ms3, lot number for cartridge (10)210729 and tubing lot#4122813, no further details provided.(b)(4).

• Brand Name: CARTRIDGE, 3ML RG MEDICATION
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD
• MDR Report Key: 13810624
• MDR Text Key: 287554363
• Report Number: MW5108283
• Device Sequence Number: 2
• 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: 01/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4122813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female