MalfunctionMRZ

RG 3ML MEDICATION CARTRIDGE

Received Oct 12, 2021 · Event occurred Sep 20, 2021

Report MW5104550 · MDR key 12624186

Device

Generic name

Accessories, Pump, Infusion

Manufacturer

Chengdu Shifeng Medical Technology Co., Ltd.

Lot number

210408

Product problems

Device Alarm System
Activation, Positioning or Separation Problem

Patient

48 YR

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

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).