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

Lot Number 210408

Device Problems Device Alarm System (1012); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

Inbound, (b)(6) daughter (b)(6) 3ml syringes lot (10)210408 are hard to pull plunger.Pump alarms low volume, but 1 ml of drug is remaining in syringe; 1 ml of treprostinil is wasted everyday even with pushing and pulling plunger fully several times before drawing up treprostinil.No further details provided.(b)(4).

• Brand Name: RG 3ML MEDICATION CARTRIDGE
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
• MDR Report Key: 12624186
• MDR Text Key: 276462534
• Report Number: MW5104550
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 55555048723
• UDI-Public: 55555-0487-23
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 210408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR